The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0607-2022·Announced 2022-02-16

GE Healthcare SIGNA MR Systems cryogenic ventilation system defect recall

GE Healthcare recalled approximately 17,228 SIGNA MR magnetic resonance imaging systems because the cryogenic ventilation systems may not meet proper venting requirements. The defect could create potential safety hazards.

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 Class II recall of a medical device with a potential safety defect in the cryogenic ventilation system. The hazard is theoretical with no reported adverse events documented in the recall notice, which per the severity rubric limits the score to 3 (risk-of-harm products where injury has not yet been reported).

Plain-English summary

GE Healthcare initiated a recall of the cryogenic ventilation systems used in its SIGNA OpenSpeed MR System magnetic resonance imaging devices. Approximately 17,228 devices are included in this recall. The cryogenic ventilation system in the affected devices may not meet required venting standards.

Improper ventilation could create potential safety hazards in the operation of the magnetic resonance imaging system. The recall addresses systems that may pose risks during normal clinical use.

The affected devices were distributed nationwide throughout the United States, including Puerto Rico and the Virgin Islands, as well as to government and military facilities. International distribution also occurred, with systems supplied to more than 100 countries.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed 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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