GE Healthcare Recalls MSK 1.5T Extreme MR Scanners Due to Gas Venting Defect
GE Healthcare is recalling 97 MSK 1.5T Extreme MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text describes a hazard that could cause 'critical deprivation of oxygen' to users and patients, which constitutes a risk of serious injury or death, aligning with the 'Severe' criteria for significant injury reports or high-risk structural defects.
Plain-English summary
GE Healthcare, LLC is recalling 97 units of the MSK 1.5T Extreme MR Scanner, a diagnostic imaging device. The recall was initiated because the gas venting system may not function properly. A site reported a magnet quenching event where cryogen gas vented into the magnet room.
The hazard associated with this defect is that cryogen gas venting into the magnet room could cause critical deprivation of oxygen to users and patients. The affected units were distributed across 26 U.S. states and 31 countries outside the United States.
Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect. The specific serial numbers and system IDs for the affected units are listed in the official recall documentation.
The recalled product
- Product
- MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 97
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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