China NMPA Product Recall - Electric hydraulic multi-functional operating table
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Hefei Heersi Technology Development Co., Ltd. initiated a voluntary Class III recall for its Electric Hydraulic Multifunctional Operating Table (Registration Certificate No.: 皖械注准20152540001) as announced by the National Medical Products Administration (NMPA) on August 31, 2017. The recall was prompted by a critical discrepancy: the input power value specified on the product's nameplate and in its instruction manual did not align with the values documented in the registered product technical requirements. This inconsistency represents a significant deviation from approved product specifications. As a result, the company was required to take corrective action, specifically recalling affected units to address this labeling and documentation inaccuracy. The recall process, including details on specific models, specifications, and batches, was outlined in an attached Medical Device Recall Event Report Form. This action underscores the regulatory framework's emphasis on accurate product information and adherence to approved technical standards to ensure user safety and product integrity.
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