Agency classClass IIOur severity:Severe FDA (Devices)·Z-1480-2014·Announced 2014-04-30

GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk

GE Healthcare is recalling 1,546 MRI scanners worldwide because gradient coil connections may loosen, causing overheating, smoke, and potential fire.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a risk of fire and smoke generation in a clinical setting, which constitutes a significant injury/property-damage risk under the rubric for Severe (Score 4).

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

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Same manufacturer · GE Healthcare, LLC

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