The Recall Desk
HighFDA (Devices)·Z-0595-2022·Announced 2022-02-16

GE Healthcare MR Magnets Cryogenic Ventilation System Defect Recall

GE Healthcare is recalling 17,228 MR superconducting magnet systems because the cryogenic ventilation system 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 of medical equipment with a potential safety system defect (cryogenic ventilation not meeting requirements). No illnesses or injuries have been reported, and the hazard is stated as a potential defect rather than a confirmed widespread problem, placing this at the High severity level per the rubric.

Plain-English summary

GE Healthcare is recalling MR superconducting magnets used in the SIGNA PET/MR imaging system because the systems may have a cryogenic ventilation system that does not meet required venting standards.

The recall affects 17,228 devices. Distribution was nationwide in the United States, including Puerto Rico and the U.S. Virgin Islands, and also to U.S. military and government agencies. The systems were distributed internationally to more than 100 countries.

No illnesses or injuries have been reported in association with this issue.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
  • ventilation-system-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.

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