China NMPA Product Recall - Central monitoring software

Draeger Medical Systems, Inc., through its affiliate Draeger Medical Equipment (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its central monitoring software, announced on February 21, 2023. The recall addresses a critical issue where certain language fonts in specific models and batches of the software exhibit missing characters. This deficiency, identified in products with registration certificate number 20152212762, could potentially lead to incomplete or misinterpreted information display, which is a significant concern in a medical monitoring environment. The National Medical Products Administration (NMPA) in China is overseeing this action. As a Class III recall, the issue is not expected to cause serious adverse health consequences but requires corrective measures to ensure product reliability and user trust. Detailed information regarding the affected models, specifications, and batch numbers is available in the 'Medical Device Recall List' and a 'Medical Device Recall Event Report Form' referenced in the official NMPA notice. Users are advised to consult these documents and follow Draeger's instructions for appropriate actions, such as returning or updating the software.