Philips North America Llc: Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

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. Quantity: 56 units Lot/code info: UDI-DI: N/A Serial Numbers: 41130 70284 41047 41196 41520 70068 70630 41024 41025 41051 41139 41143 41144 41235 41286 41327 41349 41367 41424 41432 41433 70099 70202 81073 41344 41042 41229 41457 41497 41413 84370 41080 70205 41295 70996 70589 70696 81021 41179 41041 41089 41189 41226 41287 70093 41311 70260 41464 41534 70652 41011 70067 70622 70769 70983

Source

Official record: FDA (Device enforcement) ↗

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