China NMPA Product Recall - Defibrillator/Monitor

The National Medical Products Administration (NMPA) announced a voluntary Level III recall initiated by GS Elektromedizinische Gerate G. Stemple GmbH, with the recall notice published on August 25, 2021. This action, reported by Meizhong Mutual Benefit (Beijing) International Trading Co., Ltd., concerns specific models and batches of the Defibrillator/Monitor system, particularly the Corpuls 3SLIM defibrillator/pacing unit (model 04301). The primary issue identified is a rare possibility that these units may fail to initiate treatment if subjected to impact after being dropped from heights exceeding their specified operational range. This potential safety risk prompted the manufacturer to proactively remove the affected medical devices from circulation. Further detailed information regarding the specific product models, specifications, and batch numbers involved is contained within the "Medical Device Recall Event Report Form." This voluntary Level III recall signifies that the product defect has a remote probability of causing serious adverse health consequences, underscoring the NMPA's regulatory oversight to ensure medical device safety and prompt corrective actions.