The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0610-2022·Announced 2022-02-16

GE Healthcare MRI Superconducting Magnets: Cryogen Ventilation System Defect

GE Healthcare is recalling 17,228 MRI systems because the cryogen ventilation system may not meet venting requirements. The company is providing field corrections to ensure proper ventilation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device with a safety-related deficiency in cryogen ventilation systems. Although no illnesses or injuries have been reported, improper ventilation of cryogenic systems poses a risk of harm to patients and medical personnel.

Plain-English summary

GE Healthcare has recalled 17,228 superconducting magnet components used in Brivo MR355 and Optima MR360 MRI systems. The cryogen ventilation systems may not meet the required venting specifications.

The affected systems were distributed nationwide across the United States, including Puerto Rico and the Virgin Islands, and internationally to numerous countries. Healthcare facilities operating these systems should contact GE Healthcare for verification and corrective action information.

GE Healthcare is providing field corrections to address this issue and ensure that cryogen ventilation systems meet safety requirements. Facilities should work with the manufacturer to implement appropriate corrective measures.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
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 →

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