The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

Related recalls

Same manufacturer · Philips North America

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Same hazard · fire

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