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SmartPath to dStream 3.0T (Philips) – Gradient Coil Failure (2025)

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

High

FDAJun 30, 2025Nationwide• Philips North America

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

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SmartPath to dStream 3.0T (Philips) – Gradient Coil Failure (2025)

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

MR 7700 (Philips) – Gradient Coil Failure (2025)

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

Ingenia 3.0T CX (Philips) – Gradient Coil Failure (2025)

Ingenia 1.5T (Philips) – Gradient Coil Failure (2025)

DreamStation Auto BiPAP (Philips Respironics) – Configuration Error (2025)

Achieva XR (Philips) – Gradient Coil Failure (2025)

Cotton Candy Twirl Bar (Rich Ice Cream) – Listeria Risk (2025)

Savagely Sour Cherry Bar (Rich Ice Cream) – Listeria contamination (2025)

BlueRasberry Bar (Rich Ice Cream) – Listeria Risk (2025)

Crumbled Cookie Bar (Rich Ice Cream) – Listeria contamination (2025)

Cool Watermelon Bar (Rich Ice Cream) – Listeria Risk (2025)

LYFO-DISK M. Canis (Microbiologics) – Microorganism Recovery (2025)

Strawberry Shortcake Bar (Rich Ice Cream) – Listeria contamination (2025)

Chocolate Crunch Cake Bar (Rich Ice Cream) – Listeria Risk (2025)

Orange Cream Bar (Rich Ice Cream) – Listeria contamination (2025)

Fudge Frenzy Bar (Rich Ice Cream) – Listeria contamination (2025)

Injection Needle (Spiggle & Theis) – Cytotoxicity Risk (2025)

Penicillin G Potassium (Sandoz) – Labeling Mix-Up (2025)