China NMPA Product Recall - Ultrasonic Doppler fetal heart rate monitor

Shenzhen Anbao Technology Co., Ltd. initiated a voluntary Level III recall for one unit of its Ultrasonic Doppler Fetal Heart Rate Monitor (Registration Certificate No.: 粤械注准20172231485号), as reported on July 24, 2019. This action was undertaken in response to identified non-conformities with regulatory requirements governing medical devices. The primary issues involved incorrect label information symbols on the product and the omission of critical technical data regarding sound output levels within the instruction manual. Operating under the oversight of the National Medical Products Administration (NMPA), referenced by Index No. JGXX-2019-10472, the company acknowledged these deficiencies. To address the violations, Shenzhen Anbao Technology Co., Ltd. has committed to a proactive recall of the affected device. Corrective actions include the replacement of the non-compliant product label and a revision of the instruction manual to incorporate the previously missing technical data on sound output levels. This ensures the device meets safety and information disclosure standards, providing complete and accurate information to medical professionals using the device for detecting fetal heart rate information.