China NMPA Product Recall - Color Doppler ultrasound diagnostic instrument

GE Healthcare (China) Co., Ltd. initiated a voluntary Class III recall of 51 units of its Color Doppler Ultrasound Diagnostic Instruments, specifically the LOGIQ V5 Expert model. The recall was reported on September 18, 2017, and publicly announced by the National Medical Products Administration (NMPA) on September 25, 2017. The primary issue prompting this action was the discovery of incorrect medical device registration certificate numbers printed on the product labels and in the accompanying manuals. GE Healthcare clarified that this discrepancy was a labeling and documentation error and was unrelated to the safety or performance of the ultrasound devices themselves. Under the regulatory oversight of the NMPA, GE Healthcare's corrective actions include directly notifying affected customers via email about the identified issue. Furthermore, company engineers are dispatched to conduct on-site corrections for the affected products, which involves replacing the incorrect labels and manuals with compliant versions, all provided free of charge to customers. This recall ensures adherence to Chinese medical device regulatory requirements regarding product identification and documentation.