GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk

Plain-English summary

GE Healthcare, LLC is recalling 1,546 units of Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM magnetic resonance diagnostic devices. The recall covers 704 units in the United States and 842 units outside the US, with distribution across numerous countries worldwide.

The recall is due to a potential safety issue with the gradient coil electromechanical connections. These connections may loosen, causing an increase in electrical resistance. The increased resistance can lead to increasing heat during scanning, which may cause material in the Rear Endbell enclosure to overheat. This overheating can generate smoke in the scan room and cause localized fire.

The affected devices are distributed nationwide in the US (excluding North Dakota and Rhode Island, including DC, GU, and PR) and in many international locations. No specific consumer action is detailed in the provided source text, but the hazard involves fire and smoke generation during operation.

The recalled product

Product

GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.

Manufacturer

GE Healthcare, LLC

Category

Medical Device — Magnetic Resonance Imaging (MRI)

Hazard

• fire
• smoke
• overheating

Distribution

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