The Recall Desk
HighFDA (Devices)·Z-0606-2022·Announced 2022-02-16

GE Healthcare MRI Systems Recalled for Inadequate Cryogen Ventilation

GE Healthcare SIGNA HFO/I MR Systems may have cryogen ventilation systems that do not meet venting requirements. Approximately 17,228 systems are affected nationwide 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 a Class II recall with no reported illnesses, injuries, or deaths mentioned in the source. The hazard is theoretical—the ventilation system could potentially fail to meet requirements. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3. This represents a risk-of-harm product category where injury has not yet been reported.

Plain-English summary

GE Healthcare is recalling the superconducting magnets used in SIGNA HFO/I MR Systems (nuclear magnetic resonance imaging systems) because the cryogen ventilation system in the affected units could fail to meet venting requirements.

Approximately 17,228 systems have been distributed nationwide, including Puerto Rico and the Virgin Islands, as well as to U.S. government and military facilities and more than 80 countries worldwide. Healthcare facilities and medical imaging centers using these systems may be affected.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI System Component
Hazard
  • ventilation-defect
  • cryogen-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