China NMPA Product Recall - Injection pump

Shenzhen Mindray Technology Co., Ltd. initiated a voluntary Class III recall for certain models of its injection pumps, specifically SP3D and SP5. The company submitted its recall report on August 13, 2019, which was subsequently announced by the National Medical Products Administration (NMPA) on August 16, 2019, under Index No. JGXX-2019-10537. The primary reason for the recall is the discovery of an abnormal Wi-Fi connectivity malfunction in pumps manufactured during a specific period. Despite this, other performance parameters of the infusion pumps were found to be normal and the devices remained functional. This recall affects 113 units distributed within China and is managed under the regulatory framework of the NMPA, referencing relevant Guangdong Medical Device Registration Certificates. As part of the required actions, Shenzhen Mindray Technology Co., Ltd. is obligated to promptly notify all potentially impacted customers through official correspondence, outlining the recall details, necessary procedures, and methods for addressing the affected products to ensure continued medical device safety and reliability.