Agency classClass IIOur severity:Severe FDA (Devices)·Z-1934-2025·Announced 2025-06-18

Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

Philips is recalling Intera 1.5T Omni/Stellar MRI systems due to a gradient coil component failure that can produce smoke and fire, risking patient and operator injury or death.

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: This is an FDA Class II recall involving a medical device with a potential to cause serious injury or death (smoke inhalation, burns, asphyxia) due to a structural component failure. The source text explicitly identifies death as a possible consequence, meeting the Severe threshold.

Plain-English summary

Philips North America is recalling the Intera 1.5T Omni/Stellar MRI system (Product Number 781104, Serial Numbers 10403 and 18969) due to a component failure in the gradient coil that can act as a heat source and potentially generate smoke or fire.

If smoke or fire occurs during operation, patients and MRI operators face risks including smoke inhalation, burns, asphyxia, injury, and in serious cases, death. The failure can also cause property damage.

The affected units have been distributed worldwide, including to sites in Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, South Dakota, and internationally in Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain. This is a Class II recall from the FDA.

Affected facilities and operators should immediately contact Philips North America regarding service and mitigation options for the affected gradient coil systems.

The recalled product

Product: Intera 1.5T Omni/Stellar; Product Number: 781104;
Manufacturer: Philips North America
Category: Medical Device — MRI System
Hazard: fire
smoke-inhalation
burn-injury
heat-source
Affected units: 2

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 (4)

Product Number: 781104
UDI-DI: no UDI
Serial Numbers: 10403
18969

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 →

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Same hazard · fire