The Recall Desk
HighFDA (Devices)·Z-0620-2022·Announced 2022-02-16

GE Healthcare Optima MR430s MRI systems have potential cryogenic ventilation defect

GE Healthcare recalled MR430s MRI systems because the cryogenic ventilation system may not meet required venting standards, creating potential safety risks.

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 FDA medical device recall with an identified cryogenic ventilation system defect. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).

Plain-English summary

GE Healthcare is recalling certain Optima MR430s superconducting magnet systems, which are components of nuclear magnetic resonance (MRI) imaging systems used in medical facilities. A total of 17,228 devices are included in this field action.

The magnetic resonance systems could potentially have a cryogenic ventilation system that does not meet the venting requirements.

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. The systems also have extensive international distribution across numerous countries.

The recalled product

Product
GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System, nuclear magnetic resonance imaging system.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging Equipment
Hazard
  • cryogenic-hazard
  • ventilation-failure

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.

Related recalls

Same category