Philips SmartPath MRI device recalled for potential alignment errors
Philips is recalling SmartPath to dStream 1.5T MRI systems for potential alignment errors in the MobiView image review application. 80 units affected worldwide.
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 potential software alignment error in image review functionality. No injuries or illnesses have been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Philips North America LLC is recalling SmartPath to dStream 1.5T MRI systems (model numbers 781260, 782112, and 782146) worldwide.
The recall concerns a potential for alignment errors in the cross-reference line functionality when reviewing images with the MobiView application.
The recall affects 80 units distributed worldwide, including 1 in the United States and 79 units internationally. Healthcare facilities using affected devices should contact Philips for information on corrective actions. No injuries or illnesses have been reported.
The recalled product
- Product
- Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
- Manufacturer
- Philips North America Llc
- Hazard
- alignment-error
- software-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) 781260
- (2) 782112
- (3) 782146
- UDI-DI: (1) 00884838095076
- (2) 00884838098886
- (3) 00884838108691
- Serial Numbers: (1) 10044
- 10151
- 10164
- 10170
- 11000
- 11001
- 11062
- 11076
- 12009
- 18038
- 18663
- 18872
- 18938
- 20115
Distribution
Distributed nationwide across the United States.
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