Agency classClass IIOur severity:High FDA (Devices)·Z-1862-2024·Announced 2024-05-29

Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard

Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.

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 an FDA Class II recall for a risk-of-harm product—a medical device with a potential electrical fire hazard—where no illnesses or injuries have been reported. The hazard is real and could occur in a hospital setting, but is currently theoretical.

Plain-English summary

Philips North America LLC is recalling approximately 200 SmartPath to dStream MR (Magnetic Resonance) systems used for diagnostic imaging in hospitals. The affected models are 782129, 782113, and 781270.

The recall addresses a defect in the g-MDU (global Mains Distribution Unit) L3 terminal connection. This connection may become loose over time, creating a hotspot that could result in smoke or fire in the hospital's technical room where the system is located.

The recalled systems have been distributed worldwide, including throughout the United States, Canada, and numerous countries in Europe, Asia, and the Middle East. Hospitals and medical facilities with affected units should contact Philips immediately for repair or replacement instructions.

The recalled product

Product: SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: fire
smoke
electrical-hazard
Affected units: 200

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: (1) 782129 (01)00884838105805(21)
(2) 782113 (01)00884838098909(21)

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