GE Healthcare MRI systems recalled for cryogen ventilation system defect
GE Healthcare Discovery MR450 MRI systems may have cryogen ventilation systems that do not meet required venting standards. The recall affects approximately 17,228 devices distributed in the U.S. and internationally.
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: FDA Class II classification combined with a defect in a safety-critical system (cryogen ventilation) on medical imaging equipment constitutes a risk-of-harm product situation. The ventilation system defect could create potential hazards, meeting High severity criteria despite the absence of reported incidents.
Plain-English summary
GE Healthcare is recalling Discovery MR450 1.5T magnetic resonance (MRI) systems containing superconducting magnet components. The recalled systems may have cryogen ventilation systems that do not meet the required venting requirements.
The recall affects approximately 17,228 devices. Distribution includes the United States (including Puerto Rico and the Virgin Islands), U.S. government and military installations, and numerous countries worldwide.
Affected facilities should contact GE Healthcare for information regarding this recall and any necessary corrective actions.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- 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
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
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