The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1842-2024·Announced 2024-05-29

MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk

Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.

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 a Class II medical device recall for a potential fire and smoke hazard from a loose electrical terminal connection. The recall does not report any injuries or incidents. This represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity classification.

Plain-English summary

The FDA has issued a Class II recall for Philips AchievaXR MR (Magnetic Resonance) systems, model 781253, affecting 35 units with identified serial numbers. These diagnostic imaging systems are used in hospital settings.

The recalled systems contain a g-MDU (global Mains Distribution Unit) L3 component with a terminal connection that may become loose, creating a hotspot that may cause smoke or fire. This fire and smoke hazard prompted the recall.

The affected systems have been distributed worldwide, including across the United States and in 28 additional countries including Canada, Germany, France, Japan, Spain, the United Kingdom, and others. Facilities with equipment matching the specific serial numbers listed in this recall are affected by this notice.

The recalled product

Product
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
Manufacturer
Philips North America Llc
Category
Medical Device
Hazard
Affected units
35

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 →

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