The Recall Desk
HighFDA (Devices)·Z-0611-2022·Announced 2022-02-16

GE Healthcare MRI Systems Recalled for Inadequate Cryogenic Ventilation

GE Healthcare has recalled 17,228 MRI systems because the cryogenic ventilation system does not meet safety requirements. Systems were distributed nationwide 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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard—inadequate cryogenic ventilation—is a confirmed design defect in a safety-critical medical imaging system, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

GE Healthcare is recalling the MR superconducting magnets, a critical component of the GE Healthcare Brivo MR355 magnetic resonance imaging (MRI) system. The recall affects 17,228 devices distributed nationwide, including Puerto Rico and the Virgin Islands, as well as numerous countries worldwide.

The recalled systems contain a cryogenic ventilation system that does not meet established venting requirements. Improper ventilation of cryogenic materials in these medical imaging systems could compromise equipment and facility safety.

Healthcare facilities and imaging centers that operate affected MRI systems should contact GE Healthcare for corrective measures. Facilities should verify whether their systems are included in this recall and follow GE Healthcare's instructions before continuing operation.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / MRI 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

See all →

Same hazard · cryogen ventilation defect

See all →