Philips Ingenia Ambition X MR systems recalled for loose terminal connection fire hazard
Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause smoke or fire in hospital technical rooms.
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: The recall is for a medical device with potential fire and smoke hazards caused by a loose electrical connection. No injuries or hospitalizations have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Philips North America LLC is recalling 509 Ingenia Ambition X Magnetic Resonance (MR) systems (Model Numbers 782138, 782109, and 781356). These are diagnostic medical devices used in hospitals.
The recall addresses a potential safety hazard in the g-MDU (global Mains Distribution Unit) L3 terminal connection. The connection may become loose, creating a hotspot that could result in smoke or fire in the hospital's technical room.
The affected units have been distributed worldwide, including across the United States and in 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.
Healthcare facilities with affected units should contact Philips immediately for remediation guidance. The FDA assigned this recall the number Z-1851-2024.
The recalled product
- Product
- Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
- Manufacturer
- Philips North America Llc
- Hazard
- fire
- smoke
- electrical-hazard
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 (3)
- UDI-DI: (1) 782138 (01)00884838108622(21)
- (2) 782109 (01)00884838098350(21)
- (3) 781356 (01)00884838090040(21)
Distribution
Distributed nationwide across the United States.
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