The Recall Desk
HighFDA (Devices)·Z-0599-2022·Announced 2022-02-16

GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defects

GE Healthcare is recalling MR superconducting magnets used in SIGNA Voyager MRI systems due to cryogen ventilation systems that may not meet venting requirements. The recall affects 17,228 devices.

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 an FDA Class II recall for a medical device component with a potential ventilation system defect. No illnesses, injuries, or deaths have been reported. The source states the systems 'could potentially' have the defect, indicating a theoretical rather than confirmed hazard, limiting severity to score 3 per rubric guidelines.

Plain-English summary

GE Healthcare is recalling MR superconducting magnets that are components of SIGNA Voyager and SIGNA Voyager Premier Edition magnetic resonance imaging systems. A total of 17,228 devices are affected by this recall.

The recalled magnets could have cryogen ventilation systems that do not meet venting requirements. This potential defect in the cryogenic ventilation system affects the design safety of the affected MRI systems.

The affected devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, as well as to U.S. government and military installations. The devices were also distributed internationally to numerous countries and territories worldwide.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging / MRI Component
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 · cryogenic ventilation defect

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