China NMPA Product Recall - Atlan anesthesia system

Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Atlan anesthesia system, as publicly reported by the National Medical Products Administration (NMPA) on August 27, 2021. The recall addresses an issue with the SW1.01 software version of the anesthesia system. This software flaw affects several ventilation modes, including PC-CMV, PC-SIMV, VC-CMV/Autoflow, and devices utilizing Autoflow and CPAP/PSV functionalities. The primary concern is the display of artifacts on the pressure and flow curves, which are critical for monitoring patients. These inaccuracies in the displayed data could potentially influence healthcare professionals' treatment decisions, thereby posing a risk to patient care. While this was a company-initiated voluntary recall rather than an inspection, Dräger is taking proactive steps under the NMPA's regulatory framework in China to mitigate potential harm. The required action is the recall of the affected anesthesia system, identified by Registration Certificate No.: 20213080093. Further comprehensive details regarding specific affected product models, specifications, and batch numbers are provided in an accompanying Medical Device Recall Event Report Form. This action underscores Dräger's commitment to product safety and compliance with medical device regulations.