Agency classClass IIOur severity:High FDA (Devices)·Z-0393-2024·Announced 2023-11-29

Philips MRI systems recalled for potential gradient coil fire hazard

Philips is recalling 102 Intera 1.5T MRI systems worldwide due to a potential gradient coil failure that could produce smoke and fire. The affected devices are identified by product numbers 781195 and 781295.

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 recall involving a potential fire and smoke hazard from gradient coil failure. While the risk of serious harm is significant, no injuries or deaths have been reported in the source material, and the hazard is characterized as potential rather than confirmed. This meets the High severity level for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips North America LLC is recalling 102 units of the Intera 1.5T MRI (magnetic resonance imaging) system. The recall is for a potential failure in the gradient coil component that could produce smoke and/or fire.

The affected systems were distributed domestically throughout the United States and internationally to numerous countries worldwide. The devices are identified by product numbers 781195 and 781295. Specific serial numbers of affected units are detailed in the FDA recall notice (Z-0393-2024).

The recalled product

Product: Intera 1.5T
Manufacturer: Philips North America Llc
Category: Medical Device — Diagnostic Imaging / MRI
Hazard: fire
smoke
component-failure
Affected units: 102

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. 781195 & 781295
UDI-DI: N/A
Serial No. 18510
18516
18529
18550
18564
18567
18578
18583
18592
18657
18660
18667
18678
18701
18709
18711
18714
18725

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

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Same hazard · fire