[pending] Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Pending LLM rewrite. Source: FDA_DEVICE Z-1788-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
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
- Category
- Medical Device — Devices
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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