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.
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 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
- Category
- Medical Device — MRI System
- Affected units
- 566
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.
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