Agency classClass IIOur severity:High FDA (Devices)·Z-1861-2024·Announced 2024-05-29

Philips Medical Device Recalled for Fire Hazard in Electrical Connection

Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.

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 Class II recall involving a potential fire hazard from a loose electrical connection in a medical device. No injuries or illnesses have been reported; the hazard is theoretical rather than confirmed, making it a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling the SmartPath to dStream for 3.0T (Model Number REF 782145), a medical device used in hospital settings. Three units are involved in this recall.

The defect concerns the global Mains Distribution Unit (g-MDU) L3 terminal connection. The connection may become loose, creating a hotspot that could cause smoke and/or fire in the hospital's technical room.

The affected units carry serial numbers 17377, 34114, and 38294. The device has been distributed worldwide, including throughout the United States and internationally 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.

Hospitals and facilities using this device should contact Philips immediately to arrange inspection, maintenance, or replacement. Do not operate the device if the terminal connection appears loose or damaged.

The recalled product

Product: SmartPath to dStream for 3.0T Model Number (REF): 782145
Manufacturer: Philips North America Llc
Category: Medical Device — Hospital Equipment / Electrical Component
Hazard: fire
smoke
electrical-hazard
Affected units: 3

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 (1)

UDI-DI: N/A Serial Numbers: 17377 34114 38294

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