Agency classClass IIOur severity:Severe FDA (Devices)·Z-1931-2025·Announced 2025-06-18

Philips Intera 1.5T Achieva Nova-Dual MRI System Fire Hazard Recall

Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.

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 structural hazard (component failure capable of generating fire and smoke) that poses explicit risks of serious injury or death through burns and asphyxia, meeting the criterion for Severe classification.

Plain-English summary

Philips North America is recalling three units of the Intera 1.5T Achieva Nova-Dual MRI system (Product Number 781173; Serial Numbers 13010, 13006, and 21501). One unit is located in the United States; two are located outside the United States.

The recalled systems have a component failure in the Gradient Coil that can act as a heat source, potentially producing smoke and/or fire. If smoke or fire occurs during operation, patients or operators may be exposed to smoke inhalation, burns, and/or asphyxia, which may result in injury or death. The issue could also lead to property damage.

The affected devices have been distributed worldwide, including to facilities in Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota in the United States, as well as to Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain internationally.

Affected users should contact Philips North America immediately regarding remediation steps for their equipment.

The recalled product

Product: Intera 1.5T Achieva Nova-Dual Product Number: 781173;
Manufacturer: Philips North America
Category: Medical Device — MRI System / Diagnostic Imaging
Hazard: fire
smoke-inhalation
burn-injury
asphyxia

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 (5)

Product Number: 781173
UDI-DI: no UDI
Serial Numbers: 13010
13006
21501

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