The Recall Desk
Severity pendingFDA (Devices)·Z-2216-2025·Announced 2025-08-06

SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;

Pending LLM rewrite. Source: FDA_DEVICE Z-2216-2025.

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
SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;
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) 781270
  • (2) 782113
  • (3) 782129
  • UDI-DI: (1) 00884838095083
  • (2) 00884838098909
  • (3) 00884838105805
  • Serial Numbers: (1) 17006
  • 17172
  • 17204
  • 17206
  • 17212
  • 17215
  • 17222
  • 17237
  • 17239
  • 17240
  • 17242
  • 17245
  • 17246
  • 17247

Distribution

Distributed nationwide across the United States.