AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253

Reason: 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

Code information: UDI-DI: N/A Serial Numbers: 35062 35028 35068 35081 35055 35069 35084 35024 35025 35070 35007 35013 35064 35071 35083 35022 35063 35074 35049 35035 35067 35004 35006 35011 35015 35016 35021 35050 35057 35061 35075 35076 35082 35085

Distribution pattern: 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.