Philips Ingenia Ambition X MR Systems recalled due to fire hazard
Philips is recalling 690 Ingenia Ambition X MR systems worldwide due to potential gradient coil component failures that could produce smoke or fire. Verify your device's model and serial number against the FDA recall list.
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: This is an FDA Class II medical device recall for a risk-of-harm product (MRI system) where no injuries or illnesses have been reported. The potential for fire and smoke resulting from gradient coil component failure presents a significant safety risk to patients and staff.
Plain-English summary
Philips North America is recalling 690 units of the Ingenia Ambition X MR system worldwide due to a potential for component failures in the gradient coil. Three model numbers are affected: 781356, 782109, and 782138.
The potential for component failures in the gradient coil may act as a heat source with potential to produce smoke and/or fire. The recall affects units distributed in the United States and internationally across numerous countries.
Healthcare facilities, patients, and providers should verify whether their equipment is included in this recall by checking the model number and matching the serial number against the FDA recall notice. The specific serial numbers for each affected model are listed in the official FDA documentation.
The recalled product
- Product
- Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
- Manufacturer
- Philips North America
- Hazard
- fire
- smoke
- overheating
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)
- Model Numbers (REF): (1) 781356
- (2) 782109
- (3) 782138
- UDI-DI: (1) 00884838090040
- (2) 00884838098350
- (3) 00884838108622
- Serial Numbers: (1) 47000
- 47001
- 47002
- 47003
- 47004
- 47006
- 47007
- 47009
- 47011
- 47012
- 47013
- 47014
- 47015
- 47016
Distribution
Distributed nationwide across the United States.
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