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FDA (Device enforcement)Recalled 2024-05-03class ii

Philips North America Llc: Achieva 3.0T TX for PET Model Number (REF): 781479

Hazard

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

Details from the source

Reason for recall: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire Distribution: Worldwide distribution - US Nationwide and the countries of 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, United Kingdom. Lot/code info: UDI-DI: N/A Serial Numbers: 43102

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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