Agency classClass IIOur severity:High FDA (Devices)·Z-1838-2024·Announced 2024-05-29

Philips MRI System Recalled for Potential Fire in Power Distribution Unit

Philips is recalling 2 Achieva 1.5T MRI systems worldwide due to a potential loose connection in the power distribution unit that could cause smoke or fire in hospital technical rooms.

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 medical device recall without reported hospitalizations or incidents. The potential for fire from a loose electrical connection is serious, but the lack of confirmed incidents and the theoretical nature of the hazard result in a severity level 3 classification.

Plain-English summary

Philips North America LLC is recalling 2 units of the Achieva 1.5T Initial MRI system (Model 781178, Serial Numbers 20282 and 20303). These systems have been distributed worldwide, including throughout the United States and in Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.

The g-MDU (global Mains Distribution Unit) L3 terminal connection in these systems may become loose, creating a hotspot. This condition could result in smoke and/or fire in the hospital's technical room.

Healthcare facilities that have received these specific serial numbers should immediately contact Philips North America LLC. The FDA classified this as a Class II recall. Facilities should not continue to operate the affected systems. An authorized Philips service representative must inspect the terminal connection and perform any necessary repairs.

The recalled product

Product: Achieva 1.5T Initial system Model Number (REF): 781178
Manufacturer: Philips North America Llc
Category: Medical Device — Medical Imaging
Hazard: fire
electrical-fault
smoke
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 (2)

UDI-DI: N/A Serial Numbers: 20282
20303

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 recalled by Philips North America Llc 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 30 products in this recall →

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · fire