The Recall Desk
Severity pendingFDA (Devices)·Z-2209-2025·Announced 2025-08-06

Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;

Pending LLM rewrite. Source: FDA_DEVICE Z-2209-2025.

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 Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;
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) 781356
  • (2) 782109
  • (3) 782138
  • UDI-DI: (1) 00884838090040
  • (2) 00884838098350
  • (3) 00884838108622
  • Serial Numbers: (1) 47000
  • 47001
  • 47002
  • 47003
  • 47004
  • 47006
  • 47007
  • 47009
  • 47011
  • 47012
  • 47013
  • 47014
  • 47015
  • 47016

Distribution

Distributed nationwide across the United States.