The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0460-2023·Announced 2022-12-14

Philips Ingenia Elition X MR System Gradient Coil Fire and Smoke Hazard

Philips is recalling 566 Ingenia Elition X MRI systems nationwide. The gradient coil may act as a heat source with the potential to produce smoke and/or fire.

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: FDA Class II medical device recall with potential fire and smoke hazard from gradient coil. No illnesses, injuries, or deaths reported. Per rubric, a risk-of-harm product where injury has not yet been reported qualifies as High severity.

Plain-English summary

Philips North America LLC is recalling the Ingenia Elition X MR System (an MRI scanner), Model Numbers 781358, 782107, 782119, and 782136. A total of 566 affected devices have been distributed nationwide.

The gradient coil component in these systems may act as a heat source with the potential to produce smoke and/or fire.

This recall affects hospitals, imaging centers, medical facilities, and other healthcare providers that operate these systems throughout the United States.

If you operate or maintain one of these affected MRI systems, contact Philips North America LLC immediately for further instructions on how to address this issue.

The recalled product

Product
Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging
Hazard
Affected units
566

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 (5)

  • Model 781358: UDI-DI: 00884838088115
  • Model Number 782107: UDI-DI: 00884838098336
  • Serial Numbers: 45563 45570
  • Model Number 782119: UDI-DI: 00884838104129
  • Serial Numbers: Included in Letter but No Devices Distributed in US

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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