The Recall Desk
HighFDA (Devices)·Z-0461-2023·Announced 2022-12-14

Philips MRI System Recall Due to Fire and Smoke Risk

Philips SmartPath to Ingenia Elition X MR System models may produce smoke or fire due to gradient coil heat. Recall affects 566 units nationwide.

What this means for you

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 potential fire and smoke hazard with no reported injuries or illnesses. The FDA classification is Class II. Per the rubric, theoretical hazards without reported incidents are at most High (3).

Plain-English summary

Philips North America LLC is recalling the SmartPath to Ingenia Elition X MR System (Models 782118, 782132, and 782144) due to a safety hazard in the gradient coil. The gradient coil may act as a heat source with potential to produce smoke and/or fire.

The recall involves 566 units distributed nationwide. This is an MRI system used in medical facilities.

Patients and healthcare facilities using these systems should contact the manufacturer for guidance on repair, replacement, or other remediation. The FDA classified this as a Class II recall.

The recalled product

Product
Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144
Manufacturer
Philips North America Llc
Hazard
  • fire
  • smoke
  • heat

Distribution

Distributed nationwide across the United States.