Ingenia Ambition S MRI devices recalled for alignment errors
Philips is recalling certain Ingenia Ambition S MRI devices due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a medical device with no reported illnesses or injuries. The hazard is a software functionality error that could affect image interpretation but no adverse health consequences have been documented.
Plain-English summary
Philips North America LLC is recalling certain Ingenia Ambition S magnetic resonance imaging (MRI) devices due to a potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
The affected devices are Model Numbers 781359, 782108, and 782139. A total of 152 units have been distributed worldwide, including 25 units in the United States and 127 units outside the U.S. across multiple countries.
Misalignment of the cross reference line could impact the accuracy of image review. Affected users should contact Philips for further information regarding this issue and any necessary corrective actions.
The recalled product
- Product
- Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- software-malfunction
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: (1) 781359
- (2) 782108
- (3) 782139
- UDI-DI: (1) 00884838090057
- (2) 00884838009813
- (3) 00884838098299
- Serial Numbers: (1) 48001
- 48005
- 48009
- 48011
- 48014
- 48016
- 48023
- 48033
- 48034
- 48043
- 48045
- 48047
- 48122
- 48154
Distribution
Distributed nationwide across the United States.
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