The Recall Desk
SevereFDA (Devices)·Z-0128-2021·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.

What this means for you

Illness, injury, or structural failure has been reported. 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, risk-of-harm products with significant injury potential are classified as Severe.

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 within the Power Gradient & RF (PGR) Cabinet. The affected models are 5741000-23 and 5396469.

The devices were distributed worldwide, including in the United States (specifically Florida, Kentucky, North Carolina, New Jersey, New Mexico, New York, Texas, Utah, and Washington) and in Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico, and Uzbekistan.

The source text does not specify the required actions for consumers or healthcare facilities, nor does it report any injuries or illnesses associated with this defect.

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: 5741000-23 and 5396469

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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · electrical arc flash

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