The Recall Desk
HighFDA (Devices)·Z-1932-2025·Announced 2025-06-18

Philips MRI System Recall Due to Potential Fire and Smoke Risk

Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a potential component failure in the gradient coil that could generate heat, smoke, and fire, creating risks of burns, smoke inhalation, and asphyxiation.

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 an FDA Class II recall involving a medical device with potential for serious harm (fire, smoke, burns, asphyxiation, and death). No injuries or illnesses have been reported. The hazard is potential rather than realized, fitting the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Philips North America is recalling one Intera 1.5T Explorer/Nova Dual MRI system (Product Number 781108, Serial Number 9025). An identified issue in the gradient coil component can potentially act as a heat source, producing smoke and/or fire.

If smoke or fire occurs, patients and operators may be exposed to inhalation of smoke, burns, and asphyxiation, which may lead to injury or death. Property damage is also possible.

The affected unit has been distributed worldwide.

The recalled product

Product
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Manufacturer
Philips North America
Category
Medical Device — Diagnostic Imaging
Hazard
  • fire
  • smoke
  • burn-injury
  • asphyxiation
  • property-damage

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 (3)

  • Product Number: 781108
  • UDI-DI: no UDI
  • Serial Number: 9025

Distribution

Distributed nationwide across the United States.

Related recalls

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