The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0129-2021·Announced 2020-10-28

GE Healthcare Recalls MRI Systems Due to Electrical Arc Flash Risk

GE Healthcare is recalling 30 MRI systems worldwide due to a potential electrical arc flash hazard within the power 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 is classified as FDA Class II and involves a potential electrical arc flash, which poses a significant risk of injury or property damage, meeting the criteria for a Severe rating.

Plain-English summary

GE Healthcare, LLC is recalling 30 whole-body magnetic resonance imaging (MRI) systems. The recall is issued because of a potential electrical arc flash hazard identified within the Power Gradient & RF (PGR) Cabinet of the devices.

The affected units are distributed worldwide, including nationwide in the United States and in specific states such as Florida, Kentucky, North Carolina, New Jersey, New Mexico, New York, Texas, Utah, and Washington. International distribution includes Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico, and Uzbekistan. The specific models involved are 5352293, 5726207-5, 5741000-25, and 5741000-29.

This recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences. Healthcare facilities and users should contact GE Healthcare for instructions on how to address the potential electrical hazard.

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 (3)

  • Model: 5352293
  • 5726207-5
  • 5741000-25 and 5741000-29 .

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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