Agency classClass IIOur severity:Severe FDA (Devices)·Z-1929-2025·Announced 2025-06-18

Philips Intera 1.5T Achieva IT Nova MRI System Gradient Coil Fire Risk

Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, 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 with a medical device that poses significant risks of harm including burns, asphyxiation, and potential death if the hazard manifests, meeting the Severe criterion for risk-of-harm products where serious injury or death is explicitly mentioned as a potential consequence.

Plain-English summary

Philips North America is recalling one Intera 1.5T Achieva IT Nova MRI system (Product Number 781175, Serial Number 15003) due to a potential component failure in the gradient coil. The affected component can act as a heat source and potentially produce smoke and/or fire.

If smoke or fire occurs, patients or operators may be exposed to inhalation of smoke, burns, and/or asphyxia, which may lead to injury or even death. The issue could also result in property damage.

The affected system was distributed worldwide, including in the U.S. states of Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota, as well as in Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain. Philips North America is the recalling firm. Healthcare facilities and operators in possession of this system should contact Philips for further guidance.

The recalled product

Product: Intera 1.5T Achieva IT Nova Product Number: 781175
Manufacturer: Philips North America
Category: Medical Device — MRI System
Hazard: fire
smoke-inhalation
burn-injury
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: 781175
UDI-DI: no UDI
Serial Number: 15003

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