Agency classClass IIOur severity:High FDA (Devices)·Z-1933-2025·Announced 2025-06-18

Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

Philips is recalling two Intera 1.5T MRI systems due to a gradient coil component failure that can produce smoke or fire, posing risks of inhalation injury, burns, asphyxia, 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 3/5 (High).

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 risk-of-harm product (fire, smoke inhalation, burns, asphyxia, and potential death). The source text describes the potential hazard but does not report any illnesses or injuries that have actually occurred, keeping it at the High threshold rather than Severe or Critical.

Plain-English summary

Philips North America is recalling two Intera 1.5T Master/Nova MRI systems (Product Number 781106; Serial Numbers 8009 and 18863) due to an identified component failure in the gradient coil. This failure can act as a heat source and potentially produce smoke and/or fire during operation.

If smoke or fire occurs, patients and operators face risks including inhalation of smoke, burns, asphyxia, and potentially fatal injury. The systems are located 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).

Affected facilities should immediately cease use of the recalled systems and contact Philips North America for instructions on inspection, repair, or replacement. The FDA classified this recall as Class II.

The recalled product

Product: Intera 1.5T Master/Nova Product Number: 781106;
Manufacturer: Philips North America
Category: Medical Device — Magnetic Resonance Imaging (MRI)
Hazard: fire
smoke-inhalation
burn-injury
asphyxia
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: 781106
UDI-DI: no UDI
Serial Numbers: 8009
18863

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