Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 1

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.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · Philips North America

See all →

Moderate
Philips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Moderate
Philips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
Moderate
Philips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
Moderate
Philips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Moderate
Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07

Same hazard · fire