The Recall Desk
HighFDA (Devices)·Z-0617-2022·Announced 2022-02-16

GE Healthcare MRI systems recalled for cryogenic ventilation defect

GE Healthcare MRI systems may have cryogenic ventilation systems that do not meet venting requirements. The recall affects 17,228 devices distributed nationwide and globally. Healthcare facilities should contact GE Healthcare for corrective actions.

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: FDA Class II medical device recall without reported illnesses or injuries. Improper cryogenic ventilation systems pose a risk of harm to patients and healthcare personnel, meeting the rubric criterion for High severity as a risk-of-harm product without yet-reported injury.

Plain-English summary

GE Healthcare MRI superconducting magnets, which are components of the SIGNA Horizon Cx System and related models (SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), are being recalled. These magnets may be part of systems with cryogenic ventilation systems that do not meet required venting standards.

The recall involves 17,228 devices distributed nationwide, including Puerto Rico and the Virgin Islands. Affected systems were also distributed to government and military facilities and to healthcare providers in approximately 80 countries.

Healthcare facilities and providers with affected systems should contact GE Healthcare, LLC for information about corrective actions and guidance on continued safe operation of their equipment.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Horizon Cx System (sold under SIGNA Horizon Cx, SIGNA Horizon Lx, SIGNA Infinity, SIGNA MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus), nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI System / 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 →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · cryogenic ventilation

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