Agency classClass IIOur severity:High FDA (Devices)·Z-1860-2024·Announced 2024-05-29

MRI System Mains Distribution Unit Connection Fire Risk

Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units 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: This is an FDA Class II device recall involving a risk-of-harm product (potential fire/smoke hazard in hospital environments). No injuries, illnesses, or deaths have been reported, which aligns with the criteria for Score 3: 'risk-of-harm products where injury has not yet been reported.' The fire hazard in a hospital setting is significant but without documented harm, this falls below Severe (4) classification.

Plain-English summary

Philips SmartPath to dStream for 1.5T MR (MRI) systems with model numbers 782146, 782112, or 781260 may have loose terminal connections in the global Mains Distribution Unit (g-MDU) L3 component. These are diagnostic medical devices used in hospital imaging departments.

The loose terminal connection may create an electrical hotspot that could cause smoke or fire to alarm in the hospital's technical room. No injuries or illnesses have been reported to date, but the potential for harm is significant in a hospital setting where fires pose a risk to patient and staff safety.

This recall affects 617 units that have been distributed worldwide. In the United States, affected units are distributed nationwide. Internationally, affected units have been sent to Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.

Facilities with affected units should identify devices matching the specific serial numbers listed in the recall and contact Philips North America LLC for instructions on remediation or replacement of the g-MDU L3 component.

The recalled product

Product: SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging Equipment
Hazard: fire
electrical-hazard
Affected units: 617

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