China NMPA Product Recall - Gamma ray detection device

Taivacon Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its gamma ray detection device, as reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on August 5, 2020. The primary issue identified was a discrepancy in the software version used in marketed products compared to the version officially approved for sale in China. While the registered software version for the device (Registration Certificate No.: 20162070392) was v5.01, the company had been consistently utilizing software version v6.01 in products sold within China since 2011. Despite this inconsistency, Taivacon Medical Devices clarified that software version v6.01 underwent thorough testing prior to market placement and fully complies with all design and manufacturing specifications. Consequently, the company asserted that there is no associated safety risk to users stemming from this software deviation. The recall, categorized as Class III, primarily addresses the regulatory non-conformity regarding the disparity between the registered and distributed software versions. Detailed information concerning specific models, specifications, and batch numbers affected by this recall is available in the associated Medical Device Recall Event Report Form. This action underscores the importance of strict adherence to product registration requirements within the Chinese regulatory framework.