China NMPA Product Recall - Doppler ultrasound fetal monitor

Hangzhou Yuanxiang Medical Equipment Co., Ltd. initiated a Class III voluntary recall of its Ultrasonic Doppler Fetal Monitors on January 17, 2019. This action followed findings during a national medical device supervision and spot check by the National Medical Products Administration (NMPA). The primary issue identified was substandard durability of the device's external label, which became illegible after a wiping test.An internal investigation revealed the root cause: production personnel neglected to apply a protective coating to the label during manufacturing, and subsequent inspection personnel failed to identify this critical omission before product release. The affected product, identified by Production Batch TJ20160601 and Model T1, comprised a single unit that had not been sold and was still undergoing national sampling inspection.In response, Hangzhou Yuanxiang Medical Equipment Co., Ltd. implemented corrective actions, including penalizing departmental heads and operators with performance deductions. The company also mandated comprehensive pre-job training, clarified job responsibilities, and provided targeted training on production process testing and corrective measures, encompassing recall procedures and factory testing. The singular affected unit will be relabeled upon its return from inspection to ensure compliance with quality standards.