Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
Pending LLM rewrite. Source: FDA_DEVICE Z-2200-2025.
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 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;
- 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) 781177
- (2) 781277
- (3) 781278
- (4) 781344
- (5) 781345
- UDI-DI: (1) None
- (2) None
- (3) 00884838004139
- (4) None
- (5) None
- Serial Numbers: (1) 17008
- 17011
- 17017
- 17030
- 17035
- 17038
- 17039
- 17043
- 17049
- 17051
Distribution
Distributed nationwide across the United States.
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