The Recall Desk
HighFDA (Devices)·Z-0592-2022·Announced 2022-02-16

GE Healthcare MRI superconducting magnets recalled for improper cryogen venting

GE Healthcare has recalled SIGNA Pioneer MRI systems due to potential cryogen ventilation defects that do not meet safety requirements. Approximately 17,228 devices are affected 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 Class II recall concerns a potential defect in the cryogen ventilation system of a medical device component. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as a risk-of-harm product without documented injury, warranting a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling MR superconducting magnets used in the SIGNA Pioneer System, a nuclear magnetic resonance (MRI) imaging system. The recall affects approximately 17,228 devices and is classified as a Class II recall by the FDA.

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements. These systems are found in the superconducting magnets component of the SIGNA Pioneer System.

The affected devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution extended to more than 100 countries.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging / Radiology
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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