China NMPA Product Recall - Anesthesia system

On December 13, 2021, Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its anesthesia systems. This action, reported by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration, addresses a critical safety concern. The recall stems from a rare incident where a Perseus A500 anesthesia machine detached from a Dräger Movita suspension system during user operation. The core issue identified relates to a potential safety risk arising from improper user operation that led to the unexpected detachment of the medical device from its support system. While characterized as a rare occurrence, the potential for detachment of an anesthesia machine during use necessitates a proactive response to safeguard patient and user safety. Under the regulatory oversight of the NMPA, Dräger Medical Devices (Shanghai) Co., Ltd. is taking the required action of a voluntary recall. This involves identifying and managing all affected anesthesia systems, specifically those referenced under Registration Certificate No.: 国械注进 20143085277. Further specifics regarding the affected product models, specifications, and batch numbers are detailed in the associated Medical Device Recall Event Report Form, indicating a structured approach to address this safety matter.