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

Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk

Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class II recall of medical device with risk of serious injury or death (smoke inhalation, burns, asphyxia) meets the Severe criterion. Although no injuries are reported to have occurred, the hazard poses significant potential harm.

Plain-English summary

Philips North America is recalling one unit of the Intera 1.5T Explorer/Nova Dual MRI system (Product Number 781108; Serial Number 9025) distributed worldwide. The system is subject to a component failure in the gradient coil that can act as a heat source with potential to produce smoke and/or fire.

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

This recall affects systems distributed in the United States (Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota) and internationally (Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain). Operators should contact Philips North America for guidance on system inspection and remediation.

The recalled product

Product
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Manufacturer
Philips North America
Category
Medical Device — MRI System
Hazard
  • fire
  • burn-injury
  • smoke-inhalation
  • asphyxia

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

Same category