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Sources: EU EUDAMED, US FDA
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The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Enforcement
Class II
·Completed·Philips North America Llc·December 27, 2023
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
FDA Recall
Completed
·Philips North America Llc·Product code JAK·March 29, 2022
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease
FDA Recall
Completed
·Advanced Research Medical, LLC·Product code MAX·March 14, 2023
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
FDA Recall
Completed
·Philips Ultrasound, LLC·Product code IYN·July 14, 2022
YelloPort Elite Universal Seal. For use in laparoscopic procedures.
FDA Recall
Completed
·Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom·Product code GCJ·June 2, 2022
bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023
bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
FDA Recall
Completed
·Vyaire Medical·Product code CBK·May 5, 2023
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
FDA Recall
Completed
·Align Technology Inc·Product code PNN·December 5, 2022
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
FDA Recall
Completed
·Abbott Laboratories, Inc·Product code JJE·September 29, 2017
ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06; ARCHITECT c16000 part number 03L77 Clinical Chemistry systems.
FDA Recall
Completed
·Abbott Laboratories, Inc·Product code JJE·September 29, 2017
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKO·December 22, 2021
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
FDA Recall
Completed
·Empowered Diagnostics LLC·Product code QKP·December 22, 2021
illumina Model NextSeq 550 Dx REF 20005715
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·May 3, 2022
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - Product Usage: The System is intended to be used as an adjunct to a moderate intensity diet and behavior modification program. All balloons must be removed 6 months after the first balloon is placed. The Obalon Balloons are administered using the Navigation System.
FDA Recall
Completed
·Obalon Therapeutics Inc·Product code LTI·May 23, 2019
illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx
FDA Recall
Completed
·Illumina, Inc.·Product code PFF·May 3, 2022
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part number 28-M4-36-250-32S; (f) Part number 28-M4-38-145-34S; (g) Part number 28-M4-38-190-38S; (h) Part number 28-M4-44-105-44S; (i) Part number 28-N4-22-099-22S; (j) Part number 28-N4-22-159-22S; (k) Part number 28-N4-24-099-24S; (l) Part number 28-N4-28-204-24S (m) Part number 28-N4-30-164-30U; (n) Part number 28-N4-32-164-28S; (o) Part number 28-N4-34-154-34U; (p) Part number 28-N4-34-209-30S; (q) RELAY PRO Custom-Made Device, REF 28NC36N19038S2590, part number 28-CMP-3062-NC; and (r) RELAY PRO Custom-Made Device, REF 28MC36A17536S2390, part number 28-CMP-3074-MC;
FDA Recall
Completed
·Bolton Medical Inc.·Product code MIH·February 22, 2024
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
FDA Recall
Completed
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVY·November 8, 2021
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
FDA Recall
Completed
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code NVZ·November 8, 2021
Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
FDA Recall
Completed
·Fukuda Denshi Co., Ltd. 2-35-8 Hongo, Bunkyo-Ku Tokyo Japan·Product code MHX·October 16, 2017
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Recall
Completed
·Materialise USA LLC·Product code HWT·July 13, 2022