MRI Device Software Misalignment Affecting Image Review in Ingenia Ambition S
Philips Ingenia Ambition S MRI systems have potential alignment errors in the cross reference line feature of the MobiView image review application. The defect could affect image interpretation accuracy.
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 where the hazard is described as potential (theoretical) with no reported injuries, illnesses, or hospitalizations. Per FDA rubric criteria, risk-of-harm products without reported injuries merit a High severity rating.
Plain-English summary
Philips is recalling 152 Ingenia Ambition S MRI systems due to a potential defect in the MobiView application, which is used to review MRI images.
The defect involves potential alignment errors in the cross reference line functionality. The cross reference line is a tool used to verify and compare images during review. Misalignment of this feature could affect the accuracy of image interpretation.
A total of 152 units have been recalled: 25 in the United States and 127 internationally. These systems have been distributed worldwide. The recalled devices are identified by specific serial numbers and UDI-DI codes: Model 781359 (UDI-DI 00884838090057), Model 782108 (UDI-DI 00884838009813), and Model 782139 (UDI-DI 00884838098299).
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
- display-defect
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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