Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
Pending LLM rewrite. Source: FDA_DEVICE Z-2202-2025.
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
- Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;
- 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) 782116
- (2) 782148
- UDI-DI: (1) 00884838099722
- (2) 00884838108714
- Serial Numbers: (1) 41017
- 41024
- 41025
- 41041
- 41042
- 41047
- 41051
- 41080
- 41089
- 41130
- 41139
- 41143
- 41144
- 41179
- 41189
- 41196
Distribution
Distributed nationwide across the United States.
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