Agency classClass IIOur severity:High FDA (Devices)·Z-1856-2024·Announced 2024-05-29

Medical Imaging System Recalled Due to Fire Risk from Loose Connection

Philips has recalled 81 Marlin 1.5T MR diagnostic systems due to a loose g-MDU terminal connection 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 a risk-of-harm product (potential fire/smoke hazard in medical equipment) where no injuries or incidents have been reported, meeting the rubric criterion for High severity. Though classified as FDA Class II, the absence of reported harm limits the score to 3 rather than 4.

Plain-English summary

Philips North America LLC has recalled 81 units of the Marlin 1.5T magnetic resonance imaging system (Model 781474) distributed worldwide, including US nationwide. The recall concerns a defect in the g-MDU (global Mains Distribution Unit) L3 terminal connection.

The terminal connection may become loose during use, creating an electrical hotspot. This hotspot may cause smoke and/or fire to occur within the hospital's technical room where the equipment is housed.

Affected units are identified by specific serial numbers provided in the FDA recall notice. Facilities with affected equipment should verify their system's serial number against the provided list and contact Philips for instructions on remediation or component replacement.

No injuries or fire incidents have been reported as of the recall notice. Facilities possessing affected units should take action immediately to address this potential fire hazard.

The recalled product

Product: Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781474
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging
Hazard: fire
smoke
electrical-hazard
Affected units: 81

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