Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
Pending LLM rewrite. Source: FDA_DEVICE Z-2201-2025.
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
- Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;
- 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) 781153
- (2) 781253
- UDI-DI: (1) None
- (2) None
- Serial Numbers: (1) 23003
- 23004
- 23005
- 23011
- 23014
- 23017
- 23020
- 23021
- 23028
- 23031
- 23035
- 23041
- 34039
- (2) 35004
- 35006
- 35007
Distribution
Distributed nationwide across the United States.
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