The Recall Desk
SevereFDA (Devices)·Z-0130-2021·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 Gradient & RF 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 is classified as FDA Class II and involves a potential electrical arc flash, which is a significant injury hazard. Per the rubric, FDA Class II recalls with significant injury reports or structural defects are rated Severe (4).

Plain-English summary

GE Healthcare, LLC is recalling 30 whole-body magnetic resonance imaging (MRI) systems. The recall is due to a potential electrical arc flash hazard identified within the Power Gradient & RF (PGR) Cabinet. The affected models are 5148810-3, 5741000-100, 5741000-26, and 5741000-27.

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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may 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. No specific instructions for immediate consumer action are provided in the source text, but the risk of electrical arc flash poses a safety concern for personnel operating or maintaining the equipment.

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: 5148810-3
  • 5741000-100
  • 5741000-26 and 5741000-27

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

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Same hazard · electrical arc flash

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