Agency classClass IIOur severity:High FDA (Devices)·Z-1836-2024·Announced 2024-05-29

Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard

Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.

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: FDA Class II medical device recall involving a potential fire and smoke hazard from loose electrical connections. No injuries or illnesses have been reported. This constitutes a risk-of-harm scenario where the hazard has not yet resulted in actual harm, justifying a High severity rating.

Plain-English summary

Philips North America LLC is recalling 1,585 Achieva 1.5T Magnetic Resonance (MR) systems (Model Numbers 781296 and 781343) used for diagnostic imaging in hospitals. These are medical electrical systems.

The recall addresses a safety hazard involving the g-MDU (global Mains Distribution Unit) L3 terminal connection. This connection may become loose, creating an electrical hotspot that could generate smoke or fire.

The affected devices have been distributed worldwide, including throughout the United States and to countries such as Austria, Belgium, Canada, China, France, Germany, Japan, United Kingdom, and 20 others. Specific serial numbers for both model variants are identified in the recall notice.

Healthcare facilities operating affected systems should contact Philips for replacement or repair instructions. No injuries or illnesses have been reported. Facility operators should verify their device serial numbers against the recall list and follow manufacturer guidance to mitigate fire hazards.

The recalled product

Product: Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
smoke
electrical-hazard
Affected units: 1,585

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

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Same hazard · fire