The Recall Desk
HighFDA (Devices)·Z-0601-2022·Announced 2022-02-16

GE Healthcare MRI Cryogen Ventilation System Defect Recall

GE Healthcare is recalling 17,228 MRI systems due to a potential defect in the cryogen ventilation system that may not meet venting requirements. This Class II recall affects systems 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 recall for a potential equipment defect in the cryogen ventilation system. No reported injuries, hospitalizations, or deaths are documented in the source material. Per the rubric, this constitutes a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.

Plain-English summary

GE Healthcare is recalling MR superconducting magnet components used in Optima MR450w 1.5T and Optima MR450w GEM nuclear magnetic resonance (MRI) imaging systems. A total of 17,228 devices are included in this recall.

The cryogen ventilation system in these systems could potentially fail to meet venting requirements. Improper cryogen ventilation is a safety concern that could affect the safe operation of the MRI system.

The affected systems were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution includes over 70 countries.

Affected healthcare facilities should contact GE Healthcare for guidance regarding their systems and any necessary corrective actions.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Equipment
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 · cryogen ventilation defect

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