GE Healthcare MRI superconducting magnets recalled for cryogen ventilation defect
GE Healthcare is recalling 17,228 MRI superconducting magnets that may have improper cryogen ventilation systems. The defect could fail to properly vent cryogenic materials in the SIGNA 3.0T MR System.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential ventilation system malfunction in cryogenic equipment, representing a risk if not addressed but with no documented harm. Meets criterion: risk-of-harm product without reported injury.
Plain-English summary
GE Healthcare is recalling 17,228 superconducting magnets, a component of the SIGNA 3.0T MR System, which is used for magnetic resonance imaging (MRI) at medical facilities. The affected devices were distributed nationwide in the United States, including Puerto Rico and the Virgin Islands, to military and government facilities, and internationally to over 80 countries.
The recalled magnets could potentially have a cryogen ventilation system that does not meet the required venting specifications. Proper ventilation of cryogenic materials is necessary for safe operation of the MRI system.
No illnesses or injuries related to this issue have been reported. Affected healthcare facilities should contact GE Healthcare, LLC, regarding this recall.
The recalled product
- Product
- GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 3.0T MR System, nuclear magnetic resonance imaging system.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — MRI System
- 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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