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DigitalDiagnost C90 (Philips) – Ceiling Unit Failure Risk (2023)

Potential for units suspended on the ceiling to fail and fall.

FDASep 21, 2023Nationwide• Philips North America Llc

Infusomat Large Volume Pump (B. Braun) – Occlusion Alarm (2023)

Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

Very High

FDASep 21, 2023Nationwide• B. Braun Medical, Inc.

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DigitalDiagnost C90 (Philips) – Ceiling Unit Failure Risk (2023)

Infusomat Large Volume Pump (B. Braun) – Occlusion Alarm (2023)

ProxiDiagnost N90 (Philips) – Ceiling Unit Failure Risk (2023)

EasyDiagnost Eleva (Philips) – Ceiling Failure (2023)

DigitalDiagnost C90 High Performance (Philips) – Ceiling Failure (2023)

TruDi Navigation System (Acclarent) – Location Discrepancy (2023)

Advanta V12 Stent (Atrium) – Balloon Weld Failure (2023)

Monoject 60 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 20 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 12 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 6 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 1 mL Tuberculin Syringe (Cardinal Health) – Pump Compatibility (2023)

Monoject 35 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Vasoview 6 Pro (Maquet) – Packaging Error (2023)

NeuroSync EYE-SYNC (NeuroSync) – Syncing Problems (2023)

LeadCare II Test Kit (Magellan) – Plastic Cap Issue (2023)

Express Dry Seal Chest Drains (Atrium) – Setup Instructions (2023)

Ocean Water Seal Chest Drains (Atrium) – Setup Instructions (2023)

Head and Neck Procedure Kit (DeRoyal) – Syringe Recall (2023)

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)