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PERLA TL MIS Screw (SPINEART) – Incorrect Labeling (2025)

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Moderate

FDAJun 30, 2025Nationwide• SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland

Ingenia Elition S (Philips) – Gradient Coil Failure (2025)

Fire/Burn Risk

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

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PERLA TL MIS Screw (SPINEART) – Incorrect Labeling (2025)

Ingenia Elition S (Philips) – Gradient Coil Failure (2025)

Allura R8.2.x Systems (Philips) – Imaging Functionality Loss (2025)

Ingenia Ambition X (Philips) – Gradient Coil Failure (2025)

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

Ingenia Ambition S (Philips) – Gradient Coil Failure (2025)

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

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

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

HeartSine SAM Defibrillators (HeartSine) – Component Malfunction (2025)

Laser Light Show Projectors (Beyond Laser) – Remote Interlock Issue (2025)

MR 5300 (Philips) – Gradient Coil Failure (2025)

Evolution Upgrade 1.5T (Philips) – Gradient Coil Failure (2025)

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

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

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

Breathing Circuit Set (Hamilton Medical) – Tubing Crack (2025)

UIBC Assay (Beckman Coulter) – Hemoglobin Interference (2025)

RAPIDPoint 500 Wash Cartridge (Siemens) – Manufacturing Error (2025)

VITEK 2 Gram-Negative AST (bioMerieux) – Test Result Risk (2025)