Agency classClass IIOur severity:Severe FDA (Devices)·Z-1936-2025·Announced 2025-06-18

Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk

Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall with specific reports of serious injury and death risk: the source explicitly states the defect may lead to injury or even death through smoke inhalation, burns, and asphyxiation. The hazard (fire/smoke from component failure) directly creates risk of serious harm.

Plain-English summary

Philips North America is recalling SmartPath to dStream for 1.5T MRI systems (Product Number 782146, Serial Number 13013) due to a component failure risk in the gradient coil. The defect can potentially cause the gradient coil to act as a heat source and produce smoke and/or fire.

If smoke or fire occurs, patients and operators face potential hazards including smoke inhalation, burns, and asphyxiation that may lead to injury or death. Property damage is also possible.

The affected system has been distributed worldwide, including in the U.S. states of Arizona, California, Delaware, Massachusetts, Michigan, Nebraska, New York, and South Dakota, as well as in Australia, Brazil, Ecuador, Germany, Iran, Italy, Japan, Lebanon, Libya, Mexico, Poland, Portugal, and Spain.

Patients and operators should contact Philips North America or the FDA for further guidance on this medical device safety issue.

The recalled product

Product: SmartPath to dStream for 1.5T¿; Product Number: 782146;
Manufacturer: Philips North America
Category: Medical Device — MRI Equipment
Hazard: fire
smoke-inhalation
burn-injury
asphyxia
Affected units: 1

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 (3)

Product Number: 782146
UDI-DI: no UDI
Serial Number: 13013

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 9 recalled by Philips North America 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 9 products in this recall →

Same manufacturer · Philips North America

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Same hazard · fire