The Recall Desk
HighFDA (Devices)·Z-0591-2022·Announced 2022-02-16

GE Healthcare MRI magnets recalled for cryogen ventilation defect

GE Healthcare is recalling 17,228 MRI system magnets with potential cryogen ventilation defects. No injuries have been reported.

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 FDA Class II medical device recall involves a potential safety hazard without reported injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

GE Healthcare, LLC is recalling MR superconducting magnets used in GE Healthcare SIGNA Architect nuclear magnetic resonance (MRI) imaging systems. The affected 17,228 devices were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, military facilities, and internationally.

The cryogen ventilation system in these magnets may not meet specified venting requirements. No injuries or illnesses have been reported related to this issue.

Medical facilities operating affected systems should contact GE Healthcare for inspection and corrective measures. The FDA classified this recall as Class II.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI System
Hazard
  • ventilation-defect
  • cryogenic-hazard

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.

Related recalls

Same category