The Recall Desk
Severity pendingFDA (Devices)·Z-2213-2025·Announced 2025-08-06

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

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.