China NMPA Product Recall - Ultrasound diagnostic instrument

Hitachi Aloka Medical Co., Ltd. initiated a voluntary recall for its Ultrasound Diagnostic Instruments, F37 Model, as reported to China's National Medical Products Administration (NMPA) by Hitachi Medical (Guangzhou) Co., Ltd. on April 29, 2014. The recall was prompted by a discovered defect: an electrical component on the CPU motherboard that could malfunction, potentially causing smoke or a foul odor. The manufacturer confirmed this defect does not present a fire hazard or risk of serious injury, and no adverse events have been reported. Operating under the NMPA's regulatory oversight for imported medical devices, Hitachi Aloka Medical Co., Ltd. committed to replacing the defective CPU motherboards in affected products. However, this recall is primarily an overseas action, impacting units sold in Japan (identified by specific serial numbers). Crucially, none of the affected ultrasound devices were imported or sold within China. Therefore, while the NMPA was informed, Hitachi Medical (Guangzhou) Co., Ltd. is not undertaking further recall measures in China. Chinese provincial food and drug administrations were advised to strengthen their supervision. The initial recall report was dated April 25, 2014, with the NMPA publishing the announcement on May 7, 2014.