Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard
Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.
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 recall involves FDA Class II medical devices with a potential fire and electrical hazard. No illnesses or injuries have been reported; the hazard is theoretical, placing this at High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Philips North America LLC is recalling 1,517 units of Ingenia 3.0T magnetic resonance (MR) systems, which are diagnostic imaging devices indicated for medical use in hospitals and diagnostic centers.
The recall is due to a potential safety hazard with the global Mains Distribution Unit (g-MDU) L3 terminal connection. This connection may become loose, creating a hotspot that may cause smoke or fire, potentially triggering alarms in the hospital's technical room.
The affected systems have been distributed worldwide, including throughout the United States and 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. A detailed list of affected units is available from the FDA by serial number.
Healthcare facilities with affected systems should review the FDA recall notice and contact Philips North America LLC for further guidance on remediation measures.
The recalled product
- Product
- Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- electrical-hazard
- smoke
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: (1) 782103 (01)00884838098299(21)
- (2) 781377 (01)00884838009813(21)
Distribution
Distributed nationwide across the United States.
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