The Recall Desk
HighFDA (Devices)·Z-0600-2022·Announced 2022-02-16

GE Healthcare MRI Systems Recalled for Cryogen Ventilation Issue

GE Healthcare is recalling 17,228 SIGNA Artist MRI systems due to a potential defect in the cryogen ventilation system that may not meet safety venting 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: This is a medical device recall for a potential safety defect in critical equipment. The hazard—a cryogen ventilation system that 'could potentially' not meet venting requirements—represents a risk-of-harm scenario. Per the rubric, risk-of-harm products are classified as High.

Plain-English summary

GE Healthcare is recalling its MR superconducting magnets, which are components of the SIGNA Artist system used for nuclear magnetic resonance imaging. The recalled devices may have a cryogen ventilation system that does not meet the required venting specifications.

The potentially inadequate ventilation could pose a safety risk to patients, operators, and medical facilities. Affected healthcare institutions should contact GE Healthcare for information about remediation options.

The recall affects approximately 17,228 devices distributed nationwide, including Puerto Rico and the Virgin Islands, with additional international distribution to numerous countries.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment / MRI
Hazard
  • cryogen-ventilation-defect
  • safety-system-failure

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