SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
Pending LLM rewrite. Source: FDA_DEVICE Z-2216-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
The recalled product
- Product
- SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
- Manufacturer
- Philips North America
- 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 (REF): (1) 781270
- (2) 782113
- (3) 782129
- UDI-DI: (1) 00884838095083
- (2) 00884838098909
- (3) 00884838105805
- Serial Numbers: (1) 17006
- 17172
- 17204
- 17206
- 17212
- 17215
- 17222
- 17237
- 17239
- 17240
- 17242
- 17245
- 17246
- 17247
Distribution
Distributed nationwide across the United States.
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