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.
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 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
- Hazard
- fire
- smoke
- electrical-hazard
Distribution
Distributed nationwide across the United States.
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