Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: OWB
FDA class 2
Interventional Fluoroscopic X-Ray System
Adverse events in period
20,341
+52% vs. prior period (13,417)
Deaths reported
19
Recalls in period
184
Class I enforcement
20
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
19
15
Injury
107
138
Malfunction
20,211
13,264
Not specified
4
0
Most reported coded problems
Top 15Product problems
Count
Activation Failure
7,642
Radiation Output Failure
6,144
Positioning Failure
2,465
No Display/Image
1,264
Application Program Freezes or Fails to Launch
772
Failure to Advance
621
Application Program Problem
301
Mechanical Problem
224
Display or Visual Feedback Problem
217
Unintended System Motion
189
Incorrect, Inadequate or Imprecise Result or Readings
186
Noise, Audible
182
Detachment of Device or Device Component
160
Adverse Event Without Identified Device or Use Problem
139
Radiation Output Problem
133
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
20,050
Insufficient Information
288
Fall
13
Cardiac Arrest
12
Unspecified Tissue Injury
11
Needle Stick/Puncture
10
Bruise/Contusion
7
Laceration(s)
6
Hair Loss
6
Bone Fracture(s)
6
Hemorrhage/Blood Loss/Bleeding
5
Crushing Injury
5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
5
Ischemia
4
Abrasion
4
Recalls in period
184 total
FDA enforcement classification:
Class I: 20
Class II: 166
Class III: 1
Date
Recalling firm
Status
Reason
2026-05-19
Open, Classified
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
2026-05-18
Open, Classified
Philips Allura Xper and MultiDiagnost-Eleva systems
Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended
radiation exposure and additional contrast injection
2026-04-30
Open, Classified
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in
performance as they age, particularly beyond six years of service. Issues with an HDD may, depending
on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality.
Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some
cases, a system restart may temporarily restore functionality.
2026-04-30
Open, Classified
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in
performance as they age, particularly beyond six years of service. Issues with an HDD may, depending
on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality.
Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some
cases, a system restart may temporarily restore functionality.
2026-04-28
Open, Classified
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage.
Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a
certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message
Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by
restarting the system.
2026-04-28
Open, Classified
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage.
Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a
certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message
Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by
restarting the system.
2026-04-28
Open, Classified
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage.
Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a
certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message
Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by
restarting the system.
2026-04-28
Open, Classified
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
2026-04-20
Open, Classified
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-04-20
Open, Classified
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-04-20
Open, Classified
Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off.
2026-04-20
Open, Classified
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-04-20
Open, Classified
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-04-20
Open, Classified
GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON.
2026-03-31
Open, Classified
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
2026-03-12
Open, Classified
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
2026-03-10
Open, Classified
During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient.
Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system
settings and imaging conditions, as well as the applicable regulatory requirements.
2026-03-09
Open, Classified
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior
has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0,
an actual x-ray dose is applied to the patient.
2026-03-09
Open, Classified
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0,
an actual x-ray dose is applied to the patient.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-03-03
Open, Classified
Philips has identified instances where X-ray imaging may not be initiated or may occur
intermittently when using the wired foot switch.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2026-01-26
Open, Classified
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
2025-12-29
Open, Classified
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
2025-12-29
Open, Classified
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
2025-12-19
Open, Classified
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
2025-12-19
Open, Classified
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
2025-12-19
Open, Classified
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
2025-12-19
Open, Classified
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional
systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-15
Open, Classified
Philips has identified that in a limited number of impacted systems the drip tray
beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately
documented. If it is not installed, there is a potential for coolant liquid to contact electrical
components. This could lead to electrical short-circuits, which may trigger system fuses and result in
system shutdown.
2025-12-12
Open, Classified
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after the start-up, misalignment of Market Tool Overlay, and longitudinal positional error.
2025-12-12
Open, Classified
Philips has identified two (2) software issues affecting device systems that may result in loss of
imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content
and/or loss of data. Issue 1 - System remains in continuous restart mode after the start-up. Issue 2 - Longitudinal Position Error Applicable only to systems with Poly-G3 frontal stand.
2025-12-08
Open, Classified
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
2025-12-05
Open, Classified
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max
systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When
switching quickly between organ programs (OGPs) the collimation may be incorrect.
2025-10-02
Open, Classified
The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
2025-09-29
Open, Classified
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
2025-09-03
Open, Classified
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.
Showing the 100 most recent of 184 recalls — download the CSV for the full list shown here.
Adverse events by year
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Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code OWB, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-06 06:31 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.