Agency classClass IIOur severity:High FDA (Devices)·Z-1858-2024·Announced 2024-05-29

Magnetic Resonance System Loose Terminal Connection May Cause Fire

Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected 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 of a medical device with potential fire and smoke hazard from a loose electrical connection. No illnesses, injuries, or deaths reported; the hazard represents a risk-of-harm in a critical medical environment.

Plain-English summary

Philips North America LLC is recalling its MR RT (Magnetic Resonance) imaging systems, Model 781439, serial numbers 45 and 47. These medical electrical systems are indicated for diagnostic use in hospitals. The recall addresses a potential fire hazard involving the device's power distribution unit.

The global Mains Distribution Unit (g-MDU) L3 terminal connection may become loose, creating an electrical hotspot. A loose connection of this type may cause smoke or fire to develop in the hospital's technical room where the equipment is installed. No illnesses or injuries have been reported.

The two affected units have been distributed worldwide, including throughout the United States and to multiple countries in Europe, Asia, and other regions. Healthcare facilities operating these systems should contact Philips North America LLC for inspection and remediation instructions.

The recalled product

Product: MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: fire
smoke
electrical-hazard
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: 45
47

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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Same hazard · fire