The Recall Desk
HighFDA (Devices)·Z-0613-2022·Announced 2022-02-16

GE MRI superconducting magnet systems recalled for cryogen ventilation system defect

GE Healthcare is recalling 17,228 MR superconducting magnet systems due to a potential cryogen ventilation system that does not meet venting requirements. The defect could pose safety risks to healthcare facilities and their staff.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported injuries or deaths. This is a risk-of-harm product where a cryogen ventilation system defect could pose safety hazards to personnel, but no confirmed incidents have been reported, meeting the criteria for High severity.

Plain-English summary

GE Healthcare is recalling 17,228 MR superconducting magnet systems that are components of the GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, a nuclear magnetic resonance imaging device used in healthcare facilities for diagnostic imaging.

The recall is due to a potential defect in the cryogen ventilation system. The ventilation system on affected devices may not meet the manufacturer's venting requirements, which could compromise safety during system operation.

Affected systems were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution occurred to over 80 countries worldwide.

Healthcare facilities with affected systems should contact GE Healthcare for information on remediation and appropriate safety measures.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging / MRI System
Hazard
Affected units
17,228

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)

  • All systems.

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 32 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 32 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · cryogen hazard

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