Agency classClass IIOur severity:High FDA (Devices)·Z-1843-2024·Announced 2024-05-29

Evolution 1.5T MR Systems: Loose Terminal Connection Fire Risk

Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed 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: FDA Class II recall with a theoretical fire and smoke hazard but no reported injuries, illnesses, or actual incidents. Meets the criterion for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips has recalled 56 Evolution upgrade 1.5T Magnetic Resonance (MR) diagnostic imaging systems. The recall concerns the g-MDU (global Mains Distribution Unit) L3 terminal connection, which may become loose.

A loose terminal connection can create an electrical hotspot, potentially causing smoke and fire in the hospital's technical room. While the hazard is electrical in nature, no injuries, fires, or incidents have been reported to date.

The recall affects units with specific serial numbers distributed worldwide, including throughout the United States and to 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.

Hospitals and facilities using affected Evolution 1.5T MR systems should contact Philips for inspection and repair of the terminal connection. Do not operate equipment if you suspect a loose terminal connection or notice any signs of electrical hotspots or discoloration.

The recalled product

Product: Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI Systems
Hazard: fire
smoke
electrical-hazard
Affected units: 56

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