The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0459-2023·Announced 2022-12-14

Philips MRI System Gradient Coil May Produce Smoke or Fire

Philips is recalling certain Ingenia Elition S MR Systems due to a potential fire or smoke hazard from the gradient coil. The affected units are distributed nationwide in the United States.

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 recall involving a potential fire and smoke hazard from the gradient coil. No incidents, injuries, or deaths are reported in the source text. Per the severity rubric, risk-of-harm products without reported injury score as High (3).

Plain-English summary

Philips North America LLC is recalling 566 Ingenia Elition S MR Systems distributed nationwide in the United States. The recall involves three model numbers: 781357, 782106, and 782137.

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

Healthcare facilities using these systems should verify whether any recalled units are present by checking the model numbers and serial numbers against information provided by the manufacturer. Philips North America LLC will provide additional information and support regarding this recall.

The recalled product

Product
Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137
Manufacturer
Philips North America Llc
Category
Medical Device — MRI System
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 (6)

  • Model 781357: UDI-DI: 00884838088108
  • Serial Numbers: 46002 46014 46025 46065 46077 46088 46097 46109 46071
  • Model 782106: UDI-DI: 00884838098329
  • Serial Numbers: 46224 46225 46265 46269 46311
  • Model Number 782137: UDI-DI: 00884838108615
  • Serial Numbers: Included in Letter but No Devices Distributed in the 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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