China NMPA Product Recall - Central monitoring device

Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. has initiated a voluntary Class II recall for its central patient monitors (Registration Certificate No.: 20033210776). This action, announced on January 22, 2021, by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a significant software malfunction identified in the ORG-9100K and ORG-9700K models when used with the CNS-9701K central patient monitor.After January 1, 2021, the CNS-9701K experienced critical data display issues. It failed to show arrhythmia and ST segment review data, instead saving it with an incorrect 1970 timestamp. Additionally, Non-Invasive Blood Pressure (NIBP) review data was not displayed, requiring reliance solely on real-time or individual screen readouts. While live NIBP measurements were accurate, their on-screen values appeared dimmed, potentially causing user confusion.The company is undertaking this recall to rectify these software anomalies impacting the monitor's ability to present essential patient review data. This corrective action, guided by regulatory authorities, aims to uphold patient safety and data integrity. Specific details on affected product models, specifications, and batches are available in the associated "Medical Device Recall Event Report Form."