The Recall Desk
HighFDA (Devices)·Z-0614-2022·Announced 2022-02-16

GE SIGNA MRI Systems Recalled for Cryogen Ventilation Defect

GE Healthcare is recalling 17,228 MRI systems with a potential cryogen ventilation system defect that may not meet regulatory venting requirements.

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 is a Class II medical device recall for a risk-of-harm product where no injuries or illnesses have been reported. The cryogen ventilation system defect could pose a safety risk if the venting requirements are not met.

Plain-English summary

GE Healthcare is recalling GE SIGNA 3.0T with Excite MR System magnetic resonance imaging (MRI) equipment. The recalled systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

Approximately 17,228 devices are included in this recall. The systems were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. Additional distribution was made internationally.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE SIGNA 3.0T with Excite MR System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device
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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Same hazard · cryogen ventilation defect

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