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Showing 3241–3260 of 8389 results

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RefleXion X1 Radiotherapy System (Reflexion) – dose error risk (2024)

A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.

FDAApr 16, 2024CA, CT, NJ +3 more• Reflexion Medical, Inc.

COBALT XT HF CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

EVERA MRI S VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

High

FDAApr 16, 2024Nationwide• Medtronic Inc.

PRIMO MRI DR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

COBALT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

Stryker Blueprint Software (Tornier) – case planning bug (2024)

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

FDAApr 16, 2024Nationwide• Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France

Cobalt XT HF CDT-D Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

COBALT DR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

Cobalt XT DR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

PRIMO MRI VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

CROME HF QUAD CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

Medtronic Implantable Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

COBALT XT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

EVERA S VR Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

CROME VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

COBALT XT HF QUAD CRT-D Defibrillator (Medtronic) – manufacturing defect (2024)

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

FDAApr 16, 2024Nationwide• Medtronic Inc.

BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

Tri-Staple 2.0 Reload (Unknown) – cartridge damage risk (2024)

Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

FDAApr 15, 2024Nationwide

BD Pyxis MedStation Auxiliary Tower (CareFusion) – fluid ingress risk (2024)

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

FDAApr 15, 2024Nationwide• CareFusion 303, Inc.

CARDIOHELP-i System (Maquet) – patient leakage current (2024)

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

FDAApr 15, 2024Nationwide• Maquet Medical Systems USA

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