China NMPA Product Recall - Disinfector

The National Medical Products Administration (NMPA) has announced a voluntary recall initiated by Getinge Disinfection AB for specific models and batches of its Washer Disinfector products. This recall, indexed as JGXX-2020-10055 and published on January 21, 2020, was reported by Maikewei (Shanghai) Medical Equipment Co., Ltd. The primary issue identified is the absence of a crucial pure water inlet valve during the installation of affected equipment. This critical component omission poses a potential operational deficiency for the Washer Disinfectors, which are registered under certificate number 20152573838. Operating under the NMPA's regulatory oversight in China, this action is classified as a Class III recall. A Class III recall typically signifies a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Getinge Disinfection AB is taking the required action of a voluntary recall to address this installation oversight. Comprehensive details regarding the specific models, specifications, and batches impacted by this recall are outlined in the accompanying "Medical Device Recall Event Report Form." This measure ensures that potentially affected devices are identified and appropriate corrective actions are implemented to maintain product safety and efficacy standards.