The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0127-2021·Announced 2020-10-28

GE Healthcare Recalls MRI Systems Due to Potential Electrical Arc Flash

GE Healthcare is recalling 30 MRI systems due to a potential electrical arc flash hazard within the Power Gradient & RF cabinet.

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 potential electrical arc flash, which is a significant injury hazard. Per the rubric, significant injury reports or high-risk electrical hazards in medical devices typically warrant a Severe (4) rating.

Plain-English summary

GE Healthcare, LLC is recalling 30 units of the System, Nuclear Magnetic Resonance Imaging (Models 5741000 and 5741000-20). These devices are whole-body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times.

The recall is issued because of a potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. This hazard could pose a risk of electrical injury to individuals in the vicinity of the equipment.

The affected devices were distributed worldwide, including nationwide in the United States (specifically in FL, KY, NC, NJ, NM, NY, TX, UT, and WA) and in Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico, and Uzbekistan. Healthcare facilities and users should contact GE Healthcare for instructions on how to address this safety issue.

The recalled product

Product
System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Scanner
Hazard
Affected units
30

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model: 5741000 and 5741000-20

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 5 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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