Agency classClass IIOur severity:High FDA (Devices)·Z-1863-2024·Announced 2024-05-29

Philips MRI System Recall: Loose Electrical Terminal May Cause Fire

Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.

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 involving potential fire and smoke hazard from a loose electrical connection in a medical device. No reported injuries or incidents, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips SmartPath to Ingenia Elition X Magnetic Resonance (MR) systems, Model 782118, are medical electrical devices used for diagnostic imaging in hospital settings. The recall affects one unit with Serial Number 42194.

The g-MDU (global Mains Distribution Unit) L3 terminal connection in the affected system may become loose. This loose connection creates a hotspot that could generate smoke and/or fire in the hospital's technical room.

The recalled unit has been 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.

Facilities that have received this device should contact Philips North America LLC regarding this recall.

The recalled product

Product: SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
Manufacturer: Philips North America Llc
Category: Medical Device — Magnetic Resonance Imaging
Hazard: fire
smoke
electrical-hazard
Affected units: 1

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 (1)

UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194

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