The Recall Desk
HighFDA (Devices)·Z-0597-2022·Announced 2022-02-16

GE Healthcare MRI Magnets Recalled for Inadequate Cryogen Ventilation

GE Healthcare is recalling MRI magnets used in SIGNA MR355 and MR360 systems that could have cryogen ventilation systems not meeting venting requirements. These 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: FDA Class II recall of a medical device with a risk-of-harm defect (improper cryogen ventilation system). Per the severity rubric, recalls of risk-of-harm products where injury has not been reported score as High (3).

Plain-English summary

GE Healthcare, LLC is recalling 17,228 MR superconducting magnets used in SIGNA MR355 and SIGNA MR360 magnetic resonance imaging systems. These magnets are components of the MRI systems that were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as internationally to government, military, and commercial facilities across more than 80 countries.

The recall was initiated because the affected magnetic resonance systems could potentially have a cryogen ventilation system that does not meet venting requirements. A cryogen ventilation system that does not meet the applicable venting requirements may pose a potential safety concern related to the operation of the MRI equipment.

This recall affects all systems within the SIGNA MR355 and SIGNA MR360 product lines. The FDA classified this as a Class II recall.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical 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 →