Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
Pending LLM rewrite. Source: FDA_DEVICE Z-2209-2025.
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
- Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
- 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) 781356
- (2) 782109
- (3) 782138
- UDI-DI: (1) 00884838090040
- (2) 00884838098350
- (3) 00884838108622
- Serial Numbers: (1) 47000
- 47001
- 47002
- 47003
- 47004
- 47006
- 47007
- 47009
- 47011
- 47012
- 47013
- 47014
- 47015
- 47016
Distribution
Distributed nationwide across the United States.
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