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Showing 4861–4880 of 11714 results

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ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

FLIXENE Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

Low

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

FLIXENE Vascular Graft (Atrium) – Slider Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

Cerene Cryotherapy Device (Channel Medsystems) – Error Code Issue (2024)

Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

FDAMay 3, 2024Nationwide• Channel Medsystems, Inc.

FLIXENE Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

MR RT Upgrades (Philips) – Electrical Hotspot Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

Marlin 1.5T MR Systems (Philips) – Electrical Hotspot Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

Ingenia Elition X MR Systems (Philips) – Electrical Hotspot Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

MR 5300 Systems (Philips) – Electrical Hotspot Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

Ingenia 1.5T MR Systems (Philips) – Electrical Hotspot Risk (2024)

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

FDAMay 3, 2024Nationwide• Philips North America Llc

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

ADVANTA VXT Vascular Graft (Atrium Medical) – Swivel Rod Separation (2024)

Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

FDAMay 3, 2024Nationwide• Atrium Medical Corporation

Vivid Ultrasound (GE Vingmed) – DICOM Worklist Issue (2024)

GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.

FDAMay 2, 2024IL, MA, NM +2 more• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

BD Pyxis MedStation (CareFusion) – Software Configuration (2024)

If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

FDAMay 2, 2024Nationwide• CareFusion 303, Inc.

Interventional Hemodynamic Software (Philips) – Data Sync (2024)

Potential for pressure wave data synchronization from two devices may not be correct.

FDAMay 2, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

D*Clot HD Thrombectomy System (Mermaid Medical) – Bubble Leak (2024)

Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.

FDAMay 1, 2024Nationwide• Mermaid Medical A/S Frydensbergvej 25 Stenlose Denmark

Sevoflurane Vaporizer (Getinge) – Hydrogen Fluoride Risk (2024)

Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin exposure. Potential harms include irritation of respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.

FDAMay 1, 2024CA, CO, IN +4 more• Getinge Usa Sales Inc

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