China NMPA Product Recall - Electric hydraulic operating table
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MAQUET (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall for its electro-hydraulic operating tables, specifically model 7200.01B2, as announced by the National Medical Products Administration (NMPA) on September 10, 2020. This action expands upon a previous recall issued in 2019. The central issue involves the power cord plug potentially detaching from the operating table, which could expose electronic components and create a safety hazard for users.The manufacturer, MAQUET GmbH, in conjunction with MAQUET (Shanghai), is addressing this product safety concern under the regulatory oversight of the Shanghai Municipal Drug Administration. While no complaints or adverse event reports directly related to this specific problem have been received, the company chose to proactively implement the recall to ensure customer and product safety.The required action involves identifying and rectifying all affected electro-hydraulic operating tables. Detailed information regarding affected product models, specifications, and batches is provided in the accompanying "Medical Device Recall Event Report Form." This recall underscores the NMPA's role in maintaining stringent medical device safety standards and ensuring companies respond effectively to potential product deficiencies.
- Company
- MAQUET GmbH
ID · b1e91e1d-9508-42c0-ab06-3a8d56de1a5c