China NMPA Product Recall - Operating table system; Operating table system (trade name: MAGNUS); Operating table system
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Makwei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its operating table systems, including those branded MAGNUS, on February 23, 2021. The recall stems from the manufacturer's discovery of a potential defect involving internal hydraulic leakage, which could lead to an unexpected tilting of the operating table surface during use. This action was taken to uphold customer safety and ensure the continued safe and effective performance of its medical products. The company emphasized its commitment to product responsibility, noting that no adverse events related to this specific hydraulic leakage issue have been reported to date. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA) and was publicly reported via the Shanghai Municipal Drug Administration. Makwei (Shanghai) Medical Equipment Co., Ltd. has provided detailed information on the affected product models, specifications, and batches in a "Medical Device Recall Event Report Form" for stakeholders to consult. This proactive measure ensures compliance with medical device safety standards and regulatory expectations in China.
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