The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1847-2024·Announced 2024-05-29

Philips Ingenia MRI Scanner Mains Distribution Unit Fire Risk Recall

Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.

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 risk-of-harm product—a potential fire and smoke hazard in a critical medical device used in healthcare facilities. Although no injuries or illnesses have been reported, the theoretical hazard of electrical fire in a hospital environment justifies High severity per the rubric criteria for risk-of-harm products without reported incidents.

Plain-English summary

Philips North America LLC is recalling 139 units of the Ingenia 1.5T S MRI scanner (Model 781347). The recall affects units distributed across the United States and 23 other countries including Austria, Belgium, Canada, China, Germany, France, Japan, United Kingdom, and others.

The scanner contains a global Mains Distribution Unit (g-MDU) with an L3 terminal connection that may become loose during operation. A loose connection can create an electrical hotspot, which may generate smoke and/or fire in the hospital's technical room, potentially triggering facility alarms.

This is an FDA Class II recall. No injuries or illnesses have been reported. Affected healthcare facilities should verify whether they have affected serial numbers and contact Philips North America LLC immediately for inspection, repair, or replacement guidance.

The recalled product

Product
Ingenia 1.5T S Model Number (REF): 781347
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging Equipment
Hazard
Affected units
139

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 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 30 products in this recall →

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