Philips Achieva 1.5T MRI Device Recalled for Gradient Coil Fire Risk
Philips is recalling 68 Achieva 1.5T MRI machines due to potential gradient coil component failure that could produce smoke and fire. No injuries have been reported.
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: FDA Class II recall with potential for fire and smoke hazards from gradient coil component failure. No injuries or incidents reported, but the risk-of-harm classification justifies High severity per the rubric for products with unreported injury risk.
Plain-English summary
Philips North America LLC is recalling 68 units of the Achieva 1.5T Conversion MRI device. The recall addresses a potential component failure in the gradient coil that could produce smoke and/or fire.
The affected devices have been distributed nationwide in the United States and internationally across more than 40 countries worldwide.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- Achieva 1.5T Conversion
- Manufacturer
- Philips North America Llc
- Category
- Medical Device — MRI Scanner
- Hazard
- fire
- smoke
- component-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 (20)
- Product No. 781283 & 781346
- UDI-DI: (01)00884838009806(21)39001
- (01)00884838009806(21)39027
- (01)00884838009806(21)39028
- (01)00884838009806(21)39030
- (01)00884838009806(21)39032
- (01)00884838009806(21)39039
- (01)00884838009806(21)39053
- (01)00884838009806(21)39059
- (01)00884838009806(21)39061
- (01)00884838009806(21)39062
- (01)00884838009806(21)39064
- (01)00884838009806(21)39065
- (01)00884838009806(21)39066
- (01)00884838009806(21)39067
- (01)00884838009806(21)39072
- (01)00884838009806(21)39073
- (01)00884838009806(21)39074
- (01)00884838009806(21)39075
- (01)00884838009806(21)39078
Distribution
Distributed nationwide across the United States.
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