China NMPA Product Recall - Semi-automatic external defibrillator

Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Level II recall, publicized by the National Medical Products Administration (NMPA) on December 7, 2016. This action addresses a critical issue identified in certain batches of their semi-automatic external defibrillators, model AED-2100K. The company, the responsible unit in China for devices manufactured by Nippon Koden Kogyo Co., Ltd., discovered that these products failed to automatically disconnect their power supply after self-testing. This malfunction led to unintended battery depletion, potentially compromising device readiness in emergency situations. The issue was reported by the company on October 14, 2016. The recall impacts 230 units sold within China, with the product also distributed across Japan, Europe, Asia, Africa, and South America. Under the NMPA's regulatory framework for medical device recalls, Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. committed to a corrective action. This involves providing free, on-site software upgrades for all affected defibrillators. The software correction ensures that the devices properly cut off power after self-testing, thereby preventing battery drainage and ensuring operational reliability. No health hazards related to this specific phenomenon have been reported.