China NMPA Product Recall - Micro-injection pump (Model AJ5815)

Shanghai Anjie Electronic Equipment Co., Ltd. initiated a voluntary Class III recall of its micro-injection pumps (model AJ5815) on July 30, 2019. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, stems from critical software and hardware issues identified with the device. Specifically, the alarm system software required modification to reduce the alarm sound pause and recovery time from three minutes to within two minutes. Furthermore, the alarm sound itself was found to be non-compliant with national standards, indicating a potential safety concern if crucial alerts are not adequately perceived or are delayed. The recall targets products under Registration Certificate No.: 沪械注准20152540521. This measure ensures patient safety by addressing deficiencies in the device's alert mechanisms, which are vital for medical equipment like micro-injection pumps. Detailed information regarding affected models, specifications, and batches is available in the company's Medical Device Recall Event Report Form.