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Showing 1161–1180 of 1734 results

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FEM-FLEXII Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

FEM-FLEX II Arterial Cannula (Edwards) – Wire Exposure (2025)

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

FDAMay 14, 2025Nationwide• Edwards Lifesciences, LLC

Ingenia 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

MR 7700 Upgrade (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia Elition S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

SmartPath Ingenia Elition X (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

SmartPath 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Kendall SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Allon 2001 Device (Belmont Instrument) – Temperature Wrap Risk (2025)

An investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The Human Sensor Board is disconnected from the Controller Board in the Allon device AND the temperature alarms are disabled, or 2. The Water In and Water Out and Thermostat sensors are disconnected from the Human Sensor Board AND the temperature alarms are disabled, the device will proceed to heat the water above the hardware fault limit without notifying the user of the faulty condition.

FDAMay 13, 2025Nationwide• Belmont Instrument LLC

Lago X (Spectral Instruments) – Label Mismatch (2025)

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

FDAMay 13, 2025Nationwide• Spectral Instruments Inc

Evolution Upgrade 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Kendall SCD Blended Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

MR 5300 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 3.0T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia Elition X (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T CX (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ami HTX (Spectral Instruments) – Label Mismatch (2025)

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

FDAMay 13, 2025Nationwide• Spectral Instruments Inc

Ingenia Ambition S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

MR 7700 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

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