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Karl Storz Aggressive Cutter (Karl Storz) – Sterility Barrier Breach (2024)

Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.

FDAOct 11, 2024Nationwide• Karl Storz Endoscopy

Vue PACS Viewer (Philips) – Calculation Errors (2024)

A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values.

High

FDAOct 10, 2024Nationwide• Philips Medical Systems Technologies Ltd. Matam Building 8/2 Advanced Technology Center Haifa Israel

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Karl Storz Aggressive Cutter (Karl Storz) – Sterility Barrier Breach (2024)

Vue PACS Viewer (Philips) – Calculation Errors (2024)

Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

BioZorb Marker (Hologic) – Adverse Event Risk (2024)

Boston Scientific POLARx Balloon Catheter (Boston Scientific) – Use Instructions (2024)

Boston Scientific SmartFreeze Cryo Console (Boston Scientific) – Use Instructions (2024)

Cormix 150mL EVA Container (Metrix) – IV Bag Leak (2024)

SECURE 50 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Autosampler SIL-20/30 Models (Unknown) – Main Board Condensation Failure (2024)

MEDLINE Affected Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

CORMIX 500 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 1000 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

MEDLINE Medical Convenience Kits (MEDLINE) – Smoke Evacuation Pencil Issue (2024)

Imed Products Imed EVA Bag 250 mL (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 500 mL (The Metrix Company) – IV Bag Leak Risk (2024)

CORMIX 250 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 1000 mL (The Metrix Company) – IV Bag Leak Risk (2024)

SECURE 500 mL EVA Container (The Metrix Company) – IV Bag Leak Risk (2024)

Imed Products Imed EVA Bag 150 mL (The Metrix Company) – IV Bag Leak Risk (2024)