The Recall Desk
SevereFDA (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.

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: 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
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 →

Related recalls

Same manufacturer · Philips North America

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Same hazard · fire

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