China NMPA Product Recall - Electric hydraulic operating table

On April 25, 2019, Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a Class II voluntary recall of specific models of its electric hydraulic operating tables. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, following the identification of a significant safety hazard. The primary issue involves the power cord plug of the operating table's base. When the plug is disengaged, the plastic socket may inadvertently detach from the metal frame, leading to the exposure of internal electronic components. This defect presents a potential risk of personal injury to users or patients. Maikewei (Shanghai) Medical Equipment Co., Ltd. identified this potential safety concern with products holding Registration Certificate No. 20182540273. As a proactive measure to ensure patient and user safety, the company voluntarily issued this recall. The specific models, serial numbers, and batches of the affected devices are comprehensively detailed in an accompanying Medical Device Recall Event Report Form, which serves as a crucial document for identifying and managing the impacted products. This recall underscores the company's commitment to compliance and product safety standards established by regulatory bodies like the NMPA.