The Recall Desk
HighFDA (Devices)·Z-0594-2022·Announced 2022-02-16

GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

GE Healthcare is recalling MRI superconducting magnets with cryogen ventilation system defects not meeting safety requirements. The recall affects 17,228 devices distributed across the US and internationally.

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: This is an FDA Class II recall involving a potentially defective cryogen ventilation system in medical imaging equipment. While no illnesses or injuries are currently reported, cryogenic system failures pose a significant risk of harm to facility personnel and patients, warranting a High severity score per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling GE Healthcare MR superconducting magnets, which are key components of the Discovery MR750 3.0T magnetic resonance imaging (MRI) system. A total of 17,228 devices are affected by this recall.

The superconducting magnets could have a cryogen ventilation system that does not meet venting requirements. Inadequate ventilation of cryogenic materials in these systems poses potential safety risks to personnel and patients in medical facilities.

The affected systems were distributed nationwide, including Puerto Rico and the Virgin Islands. Distribution also included U.S. government and military organizations. The devices were further distributed internationally across numerous countries.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
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 ventilation defect

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