The Recall Desk
HighFDA (Devices)·Z-0602-2022·Announced 2022-02-16

GE Healthcare MRI systems recalled for cryogen ventilation system defect

GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. 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: FDA Class II classification combined with a defect in a safety-critical system (cryogen ventilation) on medical imaging equipment constitutes a risk-of-harm product situation. The ventilation system defect could create potential hazards, meeting High severity criteria despite the absence of reported incidents.

Plain-English summary

GE Healthcare is recalling Discovery MR450 1.5T magnetic resonance (MRI) systems containing superconducting magnet components. The recalled systems may have cryogen ventilation systems that do not meet the required venting requirements.

The recall affects approximately 17,228 devices. Distribution includes the United States (including Puerto Rico and the Virgin Islands), U.S. government and military installations, and numerous countries worldwide.

Affected facilities should contact GE Healthcare for information regarding this recall and any necessary corrective actions.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment / MRI System
Hazard
  • cryogenic-ventilation
  • equipment-safety

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

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