The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0605-2022·Announced 2022-02-16

GE Healthcare MR system magnets recalled due to cryogen ventilation defect

GE Healthcare is recalling 17,228 MR superconducting magnet components due to a cryogen ventilation system that may not meet required venting specifications.

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: This is an FDA Class II recall for a defective cryogen ventilation system on medical imaging equipment. The hazard is potential safety risks from improper ventilation of cryogenic materials, but no injuries or illnesses have been reported, placing this in the High category as a risk-of-harm product where injury has not been documented.

Plain-English summary

GE Healthcare, LLC is recalling approximately 17,228 MR superconducting magnet components used in SIGNA Infinity MR System and SIGNA Infinity MR System with Excite Technology (nuclear magnetic resonance imaging systems). The recalled magnets may have a cryogen ventilation system that does not meet the required venting specifications.

Improperly functioning cryogen ventilation systems could create potential safety risks associated with cryogenic material exposure. The affected systems were distributed nationwide, including Puerto Rico and the Virgin Islands, as well as to government and military facilities, and to institutions in more than 100 countries.

Customers and healthcare facilities with these systems should contact GE Healthcare for instructions on inspection, evaluation, and any necessary corrective measures.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — 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 →

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