Agency classClass IIOur severity:High FDA (Devices)·Z-0395-2024·Announced 2023-11-29

Philips MRI Gradient Coil Recall Due to Fire and Smoke Risk

Philips is recalling SmartPath to dStream 1.5T MRI systems due to a potential gradient coil failure that could produce smoke or fire. The recall affects 119 units distributed nationwide and internationally.

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 medical device recall for a potential fire and smoke hazard from gradient coil component failure. No injuries, deaths, or illnesses have been reported in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

Philips North America LLC is recalling the SmartPath to dStream for 1.5T, a medical imaging system component. The recall was initiated due to a potential failure in the gradient coil that could produce smoke and/or fire.

The recall affects approximately 119 units identified by product numbers 781260 and 782112, along with associated UDI-DI numbers.

Affected devices have been distributed nationwide in the United States and internationally to multiple countries.

The recalled product

Product: SmartPath to dStream for 1.5T
Manufacturer: Philips North America Llc
Category: Medical Device — MRI System
Hazard: fire
smoke
component-failure
Affected units: 119

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 (20)

Product No. 781260 & 782112
UDI-DI: (01)00884838095076(21)5447
(01)00884838095076(21)5463
(01)00884838095076(21)5479
(01)00884838095076(21)5490
(01)00884838095076(21)5537
(01)00884838095076(21)5546
(01)00884838095076(21)8012
(01)00884838095076(21)8025
(01)00884838095076(21)8054
(01)00884838095076(21)8086
(01)00884838095076(21)8087
(01)00884838095076(21)8091
(01)00884838095076(21)8092
(01)00884838095076(21)8110
(01)00884838095076(21)8118
(01)00884838095076(21)8178
(01)00884838095076(21)8260
(01)00884838095076(21)8311
(01)00884838095076(21)8318

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

Same manufacturer · Philips North America Llc

See all →

High
Philips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
Moderate
Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue
FDA (Devices) · 2026-09-30
Moderate
Philips MR 7700 MRI Systems Recalled for Software Issue
FDA (Devices) · 2026-09-30
Moderate
Philips Ingenia MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30
Moderate
Philips MRI Software Recall for Image Reconstruction Failure
FDA (Devices) · 2026-09-30

Same hazard · fire