MRI System Mains Distribution Unit Connection Fire Risk
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
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 device recall involving a risk-of-harm product (potential fire/smoke hazard in hospital environments). No injuries, illnesses, or deaths have been reported, which aligns with the criteria for Score 3: 'risk-of-harm products where injury has not yet been reported.' The fire hazard in a hospital setting is significant but without documented harm, this falls below Severe (4) classification.
Plain-English summary
Philips SmartPath to dStream for 1.5T MR (MRI) systems with model numbers 782146, 782112, or 781260 may have loose terminal connections in the global Mains Distribution Unit (g-MDU) L3 component. These are diagnostic medical devices used in hospital imaging departments.
The loose terminal connection may create an electrical hotspot that could cause smoke or fire to alarm in the hospital's technical room. No injuries or illnesses have been reported to date, but the potential for harm is significant in a hospital setting where fires pose a risk to patient and staff safety.
This recall affects 617 units that have been distributed worldwide. In the United States, affected units are distributed nationwide. Internationally, affected units have been sent to Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, and the United Kingdom.
Facilities with affected units should identify devices matching the specific serial numbers listed in the recall and contact Philips North America LLC for instructions on remediation or replacement of the g-MDU L3 component.
The recalled product
- Product
- SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- electrical-hazard
Distribution
Distributed nationwide across the United States.
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