The Recall Desk
HighFDA (Devices)·Z-0608-2022·Announced 2022-02-16

GE Healthcare MRI systems recalled over improper cryogen ventilation

GE Healthcare is recalling MRI systems with potentially non-compliant cryogen ventilation. Over 17,228 superconducting magnetic resonance imaging devices may have cryogen venting systems that fail to meet FDA requirements.

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 recall of MRI systems with potentially non-compliant cryogen ventilation. This is a risk-of-harm product where no injuries or illnesses have been reported, warranting a High severity score per the rubric.

Plain-English summary

GE Healthcare, LLC is recalling certain superconducting magnets that are components of the GE 0.7T SIGNA OpenSpeed with Excite MR System. This magnetic resonance imaging (MRI) system is used in medical facilities for diagnostic imaging.

The recall was initiated because the cryogen ventilation system on these devices may not meet FDA venting requirements. Approximately 17,228 devices are affected by this field correction notice.

The systems were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands. Additionally, the devices were distributed to U.S. government and military facilities, as well as to facilities in numerous countries worldwide.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI System
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