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: IYN
FDA class 2
System, Imaging, Pulsed Doppler, Ultrasonic
Adverse events in period
1,027
+143% vs. prior period (423)
Deaths reported
13
Recalls in period
85
Class I enforcement
0
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
13
7
Injury
79
49
Malfunction
931
367
Other
4
0
Most reported coded problems
Top 15Product problems
Count
Unintended System Motion
193
Material Integrity Problem
133
Application Program Freezes or Fails to Launch
86
Electrical /Electronic Property Problem
47
Poor Quality Image
39
Material Split, Cut or Torn
39
Fracture
39
Material Separation
35
Adverse Event Without Identified Device or Use Problem
34
Unintended Application Program Shut Down
32
Mechanical Jam
31
Break
29
Crack
22
Unexpected Shutdown
19
Fire
19
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
919
Insufficient Information
35
Perforation
19
Laceration(s)
11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
11
Perforation of Esophagus
5
Electric Shock
5
Shock
4
Discomfort
4
Pain
3
Cardiac Arrest
3
Unspecified Tissue Injury
2
Skin Tears
2
Sepsis
2
Pulmonary Edema
2
Recalls in period
85 total
FDA enforcement classification:
Class II: 18
Class III: 69
Date
Recalling firm
Status
Reason
2025-10-31
Open, Classified
Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-10-09
Open, Classified
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.
2025-09-18
Open, Classified
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
2025-09-18
Open, Classified
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
2025-09-18
Open, Classified
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-07-03
Open, Classified
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
2025-05-16
Open, Classified
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
2025-05-16
Open, Classified
GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previous obstetric patient data in the Whizz report. This could potentially lead to an incorrect clinical decision due to inaccuracy in the fetal size and growth calculation.
2025-03-06
Open, Classified
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
2025-03-06
Open, Classified
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
2024-09-04
Open, Classified
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
2024-08-15
Open, Classified
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
2024-08-15
Open, Classified
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
2024-08-15
Open, Classified
If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management
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 IYN, 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: 2026-07-05 21:21 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.