The Recall Desk
HighFDA (Devices)·Z-0596-2022·Announced 2022-02-16

GE Healthcare MRI Systems Recalled for Potential Cryogen Ventilation Defect

GE Healthcare is recalling approximately 17,228 SIGNA Creator and Explorer MRI systems due to potential defects in their cryogen ventilation systems that may not meet required venting standards.

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 with no reported illnesses or injuries. The hazard involves a potential cryogenic ventilation system defect. Per the severity rubric, risk-of-harm products without reported injury receive a High severity score.

Plain-English summary

GE Healthcare is recalling approximately 17,228 superconducting magnet systems used in SIGNA Creator and SIGNA Explorer magnetic resonance imaging (MRI) systems.

The recall is due to a potential defect in the cryogen ventilation system. The affected systems could have cryogen venting systems that do not meet required venting standards.

The devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands. They were also distributed internationally to numerous countries.

Users of affected systems should contact GE Healthcare for information regarding the recall.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Magnetic Resonance Imaging
Hazard
  • cryogenic-ventilation-defect

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