The Recall Desk
HighFDA (Devices)·Z-2205-2025·Announced 2025-08-06

Philips Ingenia 1.5T S gradient coils may act as heat source

Ingenia 1.5T S MR systems are being recalled because component failures in the gradient coil may act as a heat source with the potential to produce smoke or fire. 136 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Risk-of-harm product: a component that may produce smoke or fire in a scanner enclosing a patient, with no injury reported in the source.

Plain-English summary

The Ingenia 1.5T S MR system, model number 781347, UDI-DI 00884838068421, is being recalled. The action covers 136 units, with serial numbers including 81001, 81003, 81004 and 81005.

The stated reason is the potential for component failures in the gradient coil of the affected MR systems, which may act as a heat source with a potential to produce smoke and/or fire. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was worldwide, including nationwide in the United States and to Albania, Algeria and Angola among other markets. The systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the model number, UDI-DI and serial numbers above and follow the instructions issued by the manufacturer.

The recalled product

Product
Ingenia 1.5T S Model Number (REF): 781347;
Manufacturer
Philips North America
Category
Medical Device — MRI system
Hazard
Affected units
136

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 Number (REF): 781347
  • UDI-DI: 00884838068421
  • Serial Numbers: 81001
  • 81003
  • 81004
  • 81005
  • 81006
  • 81007
  • 81008
  • 81009
  • 81010
  • 81011
  • 81013
  • 81014
  • 81015
  • 81016
  • 81017
  • 81018
  • 81019
  • 81020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Related recalls

Same manufacturer · Philips North America

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Same hazard · gradient coil

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