The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0609-2022·Announced 2022-02-16

GE Healthcare 1.5T SIGNA MRI systems recalled for ventilation defect

GE Healthcare is recalling 17,228 of its 1.5T SIGNA HDe MR imaging systems because the cryogenic ventilation system does not meet required venting standards.

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 risk-of-harm medical device (MRI cryogenic system) where the identified defect in ventilation could pose safety risks. No illnesses, injuries, or hospitalizations have been reported, placing this recall in the 'High' category for risk-of-harm products without reported injury.

Plain-English summary

GE Healthcare is recalling its 1.5T SIGNA HDe MR imaging systems, specifically the superconducting magnet components. The recall affects approximately 17,228 devices distributed nationwide throughout the United States, Puerto Rico, and the Virgin Islands, as well as to government and military facilities and more than 80 countries worldwide.

The recall was initiated because the cryogenic ventilation system in these magnetic resonance systems does not meet the required venting specifications. Proper ventilation of the cryogenic system is critical to safe operation of the imaging equipment.

Healthcare facilities, imaging centers, and other institutions that operate or maintain these systems may be affected by this recall.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Magnetic Resonance Imaging System
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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