Agency classClass IIOur severity:Severe FDA (Devices)·Z-1935-2025·Announced 2025-06-18

Philips Intera Achieva 1.5T Pulsar MRI Systems Gradient Coil Fire Risk

Philips is recalling certain Intera Achieva 1.5T Pulsar MRI systems due to a potential component failure in the gradient coil that could generate smoke and/or 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: The FDA classified this as a Class II recall, and the source text explicitly describes potential for death, serious injury (burns, asphyxiation, smoke inhalation), and property damage from a component failure that could generate heat, smoke, and fire. This meets the criterion for Severe (Score 4) as a Class II with significant injury and death potential reported.

Plain-English summary

Philips North America is recalling four units of the Intera Achieva 1.5T Pulsar MRI system (Product Number 781171) distributed worldwide, including in the United States and internationally. The systems have been distributed to locations in Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, South Dakota, and internationally to Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain.

A component failure in the gradient coil of affected systems can potentially act as a heat source and produce smoke and/or fire. If smoke or fire occurs, patients or operators may inhale smoke, suffer burns, or experience asphyxiation, which may lead to injury or even death. This issue could also result in property damage.

Affected units can be identified by Serial Numbers 11044, 11039, 18627, and 11069. Customers who own or operate these systems should contact Philips North America for further guidance on this issue.

The recalled product

Product: Intera Achieva 1.5T Pulsar; Product Number: 781171;
Manufacturer: Philips North America
Category: Medical Device — MRI System
Hazard: fire
smoke-inhalation
burn-injury
asphyxiation

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 (6)

Product Number: 781171
UDI-DI: no UDI
Serial Numbers: 11044
11039
18627
11069

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