China NMPA Product Recall - Central monitoring system

On January 22, 2021, the National Medical Products Administration (NMPA) announced that Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. initiated a voluntary Class II recall of its central monitoring system (CNS-9101), including the multi-channel telemetry signal receiver ORG-9100(K). The recall stems from a significant software malfunction identified after January 1, 2021. The primary issues include the central monitoring system failing to display arrhythmia and ST segment review data, instead saving erroneous data from the year 1970. Furthermore, NIBP review data is not displayed, requiring users to rely solely on overall bedside or individual screen displays. While NIBP measurements are accurate, their values appear dimmed, potentially leading to user confusion or misinterpretation. This voluntary recall is a direct response to these critical software defects impacting patient data display and review capabilities. Affected product models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form.