The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0619-2022·Announced 2022-02-16

GE Healthcare MR superconducting magnets recalled due to cryogen ventilation system defect

GE Healthcare has recalled 17,228 MR superconducting magnets used in nuclear magnetic resonance imaging systems because the cryogen ventilation system does not meet required venting standards. The recall affects devices distributed nationwide and internationally.

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 a Class II FDA recall of medical imaging equipment involving a cryogen ventilation system defect. No illnesses, injuries, or deaths are reported in the source material. The hazard is stated as potential risk, not confirmed harm, placing this in the 'High' category per the rubric criteria for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare has recalled 17,228 MR superconducting magnets, which are components of the GE Healthcare MR MAX System used for nuclear magnetic resonance imaging. The recall was issued because the cryogen ventilation system in these devices does not meet required venting standards.

The affected devices were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands. Government and military facilities also received these systems. Additionally, the devices were distributed internationally to more than 90 countries across multiple continents.

This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

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