China NMPA Product Recall - Blood gas, blood oxygen, electrolyte and metabolite analyzer; immunoassay analyzer

On August 29, 2019, Radomet Medical Equipment (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific blood gas, blood oxygen, electrolyte, and metabolite analyzers, as well as certain immunoassay analyzers. This action was reported under National Medical Products Administration (NMPA) Index No. JGXX-2019-10574 and Shanghai Food and Drug Administration Medical Device Recall 2019-222, reflecting compliance with the national regulatory framework. The primary issue prompting the recall was a software vulnerability within the Microsoft Windows XP and Windows 7 operating systems used by some Radomet analyzers. This vulnerability could lead to memory crashes, resulting in a "blue screen of death" or unexpected system restarts for the affected devices. The required action by Radomet Medical Equipment (Shanghai) Co., Ltd. is to voluntarily recall these products to address the identified technical malfunction. Detailed information regarding affected product models, specifications, and batch numbers is provided in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks and uphold the reliability and safety of their medical equipment.