HIGH
FDA DEVICE
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
Recall database
All Product Recalls
Browse 4,434 active product recalls and safety alerts. Use search and filters to narrow the list by product, brand, hazard level, or status.
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- 222
HIGH
FDA DEVICE
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
HIGH
FDA DEVICE
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
During the
Health & Personal Care
HIGH
FDA DEVICE
NOXBOX LTD Recalls NOxBOXi Nitric Oxide Delivery System in US for Pump Failure
Replacement of the internal Sample Pump due to high failure rates.
NOXBOX
Replacement of
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Heart Rate Monitor Cap Recalled for Sizing Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Issues Recall for Newborn Heart Rate Monitor Component
Surepulse Medical recalled the VS Cap Small component of its newborn heart rate monitor on January 20, 2023. The recall stems from incorrect sizing information provided on the product label. This defect poses a significant risk to patient safety.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Heart Rate Monitor Component Over Sizing Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Surepulse Medical Recalls Newborn Heart Rate Monitor Component Due to Labeling Error
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
SUREPULSE MEDICAL
Retroactively reported;
Health & Personal Care
HIGH
FDA DEVICE
Foundation Medicine FoundationOne Liquid CDx Recall 2022 Reminds Clinicians to Check CDx Pages (18 U
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Foundation Medicine
Reports were
Health & Personal Care
HIGH
FDA DEVICE
Foundation Medicine FoundationOne CDx Recalled for Missing Companion Diagnostic Claims Page
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Foundation Medicine
Reports were
Health & Personal Care
HIGH
FDA DEVICE
Philips Ultrasound Systems Recalled Over Automatic Reboot Risk
Philips recalled 1,721 EPIQ Ultrasound Systems on July 14, 2022. The ultrasound may unexpectedly reboot, damaging the transducer. Healthcare providers must stop using the device immediately.
Philips Ultrasound
Retroactive: Ultrasound
HIGH
FDA DEVICE
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller,...
Abiomed
Retrospective submission