China NMPA Product Recall - Injection pump

Shenzhen Mindray Technology Co., Ltd. initiated a voluntary Class III recall for certain models of its injection pumps (SP3D and SP5), affecting 113 units in China. The recall, reported on August 13, 2019, was prompted by the discovery of an abnormal Wi-Fi connection issue in some devices. This anomaly means the affected pumps do not fully comply with their registered product technical specifications. Importantly, the issue primarily impacts users who integrate the pumps with an infusion monitoring system; the pumps' other performance aspects and parameters remain normal and functional for their primary purpose of intravenous medication infusion. In response to this non-compliance, Shenzhen Mindray Technology Co., Ltd. is undertaking specific corrective actions. These include promptly informing all potentially affected customers through official letters and implementing software upgrades for the implicated machines. This voluntary action aligns with regulatory expectations for addressing product deviations. The Class III designation indicates that while the technical defect exists, the use of these devices is unlikely to cause adverse health consequences to patients. The company's proactive steps aim to resolve the Wi-Fi connectivity issue and restore full compliance with product specifications.