MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
Pending LLM rewrite. Source: FDA_DEVICE Z-2213-2025.
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
- MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;
- 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) 782110
- (2) 782135
- (3) 782152
- UDI-DI: (1) 00884838099364
- (2) None
- (3) 00884838112841
- Serial Numbers: (1) 63000
- 63001
- 63006
- 63007
- 63008
- 63009
- 63010
- 63011
- 63012
- 63013
- 63014
- 63015
- 63016
- 63018
Distribution
Distributed nationwide across the United States.
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