GE Healthcare Recalls Optima 1.5T MR430s MR Scanners Due to Gas Venting Defect
GE Healthcare is recalling 101 Optima 1.5T MR430s 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 recall is classified as FDA Class II and involves a reported incident of magnet quenching with gas venting that could cause critical oxygen deprivation, meeting the criteria for Severe severity.
Plain-English summary
GE Healthcare, LLC is recalling 101 units of the Optima 1.5T MR430s MR Scanner, a diagnostic imaging device. The recall is due to a defect where gas venting may not occur properly.
A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. The source text states that cryogen gas venting into the magnet room could cause critical deprivation of oxygen to users and patients.
The affected units were distributed in 25 U.S. states and 33 countries outside the U.S. The source text does not specify instructions for consumers or healthcare facilities regarding the recall.
The recalled product
- Product
- Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 101
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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