Agency classClass IIOur severity:Severe FDA (Devices)·Z-1928-2025·Announced 2025-06-18

Philips Achieva XR MRI systems recall for fire hazard

Philips Achieva XR MRI systems may have a gradient coil component failure that can generate heat, smoke, and fire. The risk to patients and operators includes inhalation of smoke, burns, 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: The source describes a component failure capable of producing fire and smoke with potential for serious injury or death, and the recall is FDA Class II for a medical device with inherent risk of serious adverse health consequences.

Plain-English summary

Philips North America has recalled Achieva XR MRI systems (Product Numbers 781153 and 781253) due to a component failure in the Gradient Coil that can potentially act as a heat source and produce smoke and/or fire.

If smoke or a fire occurs during operation, patients or operators may be exposed to inhalation of smoke, burns, and asphyxia, which may lead to injury or even death. Property damage is also possible.

Affected units were distributed worldwide, with 5 units in the US (distributed to AZ, CA, DE, MA, MI, NE, NY, and SD) and 1 unit outside the US. All serial numbers of the affected product numbers are included in this recall.

Customers with affected systems should contact Philips North America for further guidance on the issue and corrective actions.

The recalled product

Product: Achieva XR Product Numbers: (1) 781153, (2) 781253;
Manufacturer: Philips North America
Category: Medical Device — MRI System
Hazard: fire
burn-injury
smoke-inhalation
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 Numbers: (1) 781153
(2) 781253
UDI-DI: (1) no UDI
(2) no UDI
Serial Numbers: All serial numbers

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