Agency classClass IIOur severity:High FDA (Devices)·Z-1859-2024·Announced 2024-05-29

Philips Magnetic Resonance System MR RT Upgrades Recalled for Fire Risk

Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 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 for a fire and smoke hazard caused by a loose electrical connection in the mains distribution unit. No injuries, illnesses, or deaths have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

Philips North America LLC is recalling MR RT Upgrades Magnetic Resonance (MR) systems, model 781440, used for diagnostic imaging in healthcare facilities. The systems have a defect in the global Mains Distribution Unit (g-MDU) L3 terminal connection that may become loose, creating an electrical hotspot that could generate smoke or fire.

The recalled systems were distributed worldwide to hospitals and medical centers in the United States and 29 other countries, including Canada, Germany, France, Japan, the United Kingdom, and others. Two units are identified as affected, with serial numbers 70980 and 71569.

Healthcare facilities using these systems should contact Philips North America LLC for additional information regarding this recall and any necessary corrective actions.

The recalled product

Product: MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
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: 70980
71569

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