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Showing 3381–3400 of 8389 results

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Garbin EVO Ventilator (Philips) – Power Alarm Malfunction (2024)

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Left Heart Vent Catheters (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

I.M.A. Cannulae (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

Moderate

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Disposable Pressure Display Sets (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Suction Tubes (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Vessel Cannulae (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Arterial Cannulae (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Medtronic Intracoronary Shunts (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Trilogy Evo Ventilator (Philips) – Power Alarm Malfunction (2024)

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Tourniquet Sets (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Cardioplegia Adapters (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

Threaded IM Nail (TriMed) – Driver-Socket Specification Issue (2024)

Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

FDAMar 19, 2024Nationwide• TriMed Inc.

Aeris EVO Ventilator (Philips) – Power Alarm Malfunction (2024)

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

DLP Coronary Ostial Cannulae (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

LifeVentEVO2 Ventilator (Philips) – Power Alarm Malfunction (2024)

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Trilogy Evo Universal Ventilator (Philips) – Power Alarm Malfunction (2024)

Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

FDAMar 19, 2024Nationwide• Philips Respironics, Inc.

Clearview Blower/Mister (Medtronic) – Sterile Packing Issue (2024)

Potential for unsealed sterile packing.

FDAMar 19, 2024Nationwide• Medtronic Perfusion Systems

DuraMax Stacked Tip Kit (Angiodynamics) – Metal Shavings Risk (2024)

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

Innova IGS 5 X-Ray System (GE) – Bolt Adhesive Potential Issue (2024)

GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.

FDAMar 18, 2024Nationwide• GE Medical Systems, SCS

DuraFlow 2 24cm Vasc-Pak (Angiodynamics) – Metal Shavings Risk (2024)

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

FDAMar 18, 2024VA• Angiodynamics, Inc.

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