Agency classClass IIOur severity:High FDA (Devices)·Z-1857-2024·Announced 2024-05-29

Philips MR System 1.5T Marlin MRI devices recalled due to fire hazard

Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire 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 FDA Class II recall involves a potential fire and smoke hazard from a loose electrical connection. The risk of fire or smoke in a hospital technical room represents a risk-of-harm product, fitting the High severity category.

Plain-English summary

Philips North America LLC is recalling 10 units of the MR System 1.5T Marlin, a diagnostic magnetic resonance imaging (MRI) device. The recall affects units distributed worldwide, including the United States and international facilities. The recalled units are identified by serial numbers 79010, 79008, 79006, 79009, 79011, 79003, 79004, 79002, 79012, and 79005.

The hazard involves the g-MDU (global Mains Distribution Unit) L3 terminal connection, which may become loose and create a hotspot. This condition poses a risk of smoke and/or fire in the hospital's technical room where the equipment is located.

The FDA classified this as a Class II recall. Facilities using these MR systems should contact Philips for instructions on correcting the terminal connection issue. Users should monitor the equipment for signs of electrical problems or overheating in the mains distribution unit.

The recalled product

Product: MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: fire
smoke
electrical-hazard
Affected units: 10

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