The Recall Desk
HighFDA (Devices)·Z-0616-2022·Announced 2022-02-16

GE Healthcare MR Superconducting Magnets Cryogen Ventilation System Defect

GE Healthcare is recalling 17,228 superconducting magnetic resonance imaging systems due to potential cryogen ventilation system defects 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 Class II medical device recall involving a potential safety defect in cryogenic equipment. While no injuries or illnesses have been reported and the hazard is theoretical (systems 'could potentially' have the defect), this represents a risk-of-harm product where injury has not yet been reported, meeting the threshold for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 17,228 superconducting magnetic resonance (MR) imaging systems that are components of the GE Healthcare Contour System. These systems were distributed nationwide across the United States, Puerto Rico, the Virgin Islands, and internationally to approximately 70 countries. The distribution also included military and government facilities.

The recalled MR superconducting magnets could potentially have cryogen ventilation systems that do not meet safety venting requirements. All systems included in this Class II recall notice are subject to this potential defect.

Healthcare facilities and providers operating these imaging systems should contact GE Healthcare to determine whether their equipment is affected and to learn about remediation options.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Contour System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Magnetic Resonance Imaging System
Hazard
Affected units
17,228

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 32 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · cryogenic ventilation defect

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