The Recall Desk
HighFDA (Devices)·Z-2212-2025·Announced 2025-08-06

MRI System Gradient Coil May Produce Smoke or Fire

Philips is recalling Intera 3.0T Quasar Dual MRI systems worldwide due to potential gradient coil failures that could generate smoke or fire.

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: This is FDA Class II with a risk-of-harm hazard (fire and smoke from component failure) for which no injuries or illnesses have been reported. Per the severity rubric, this qualifies as 'High': risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America is recalling the Intera 3.0T Quasar Dual MR (magnetic resonance) imaging system, Model Number 781150. The recall affects units distributed worldwide, including throughout the United States.

The gradient coil component in these systems may experience failures that could cause it to act as a heat source, potentially producing smoke and/or fire. This poses a risk of injury to patients, medical staff, and facility occupants.

The FDA classifies this as a Class II recall. No injuries or illnesses have been reported to date. Affected healthcare facilities should contact Philips North America immediately for guidance on inspection, repair, or replacement options.

The recalled product

Product
Intera 3.0T Quasar Dual Model Number (REF): 781150;
Manufacturer
Philips North America
Category
Medical Device — Magnetic Resonance Imaging
Hazard
  • fire
  • smoke
  • heat-source

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 (2)

  • Model Number (REF): 781150
  • UDI-DI: None Serial Numbers: 17123

Distribution

Distributed nationwide across the United States.

Related recalls

Same category