China NMPA Product Recall - Injection pump

Shenzhen Haoke Medical Instrument Co., Ltd. initiated a voluntary Level III recall of its HK-400 injection pumps, specifically batch number 201901006. This action, reported to the National Medical Products Administration (NMPA) on September 6, 2019, and publicly announced on September 16, 2019, addresses a critical software issue. The recall stems from a software version burning error that causes the alarm deactivation button to clear certain alarms, violating the product's technical requirements. A total of 20 units were affected, with 9 units sold in China. The company confirmed that, as of the report date, no adverse event reports related to this software defect had been received. Shenzhen Haoke will take two primary corrective actions: notifying all affected customers through formal letters to inform them about the issue and the recall process, and directly contacting these customers to schedule and perform a software upgrade on the affected injection pumps to rectify the error. This recall underscores the importance of adhering to regulatory standards for medical devices registered under certificate number 粤械注准20172541482.