Ingenia 1.5T S Model Number (REF): 781347;
Pending LLM rewrite. Source: FDA_DEVICE Z-2205-2025.
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 1.5T S Model Number (REF): 781347;
- 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 Number (REF): 781347
- UDI-DI: 00884838068421
- Serial Numbers: 81001
- 81003
- 81004
- 81005
- 81006
- 81007
- 81008
- 81009
- 81010
- 81011
- 81013
- 81014
- 81015
- 81016
- 81017
- 81018
- 81019
- 81020
Distribution
Distributed nationwide across the United States.
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