China NMPA Product Recall - Central Monitoring Workstation Sentrol Medical

On January 22, 2021, the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration announced a Class II voluntary recall initiated by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd. This recall pertains to their Central Monitoring Workstation (CNS-6201, Registration Certificate No.: 20192071912). The company reported a significant software malfunction affecting the device when integrated with the ORG-9100(K).

The primary issues, identified after January 1, 2021, include the CNS-6201 failing to correctly display arrhythmia and ST segment review data, instead defaulting to a 1970 timestamp for saved data. Furthermore, Non-Invasive Blood Pressure (NIBP) review data is not displayed on the workstation, requiring clinical staff to reference data from individual bedside screens. Although NIBP measurements are accurate, their displayed values appear dimmed, potentially impacting user readability. This voluntary recall, categorized as Class II, underscores the company's commitment to addressing device performance discrepancies under the NMPA's medical device vigilance framework. Affected product details are available in the 'Medical Device Recall Event Report Form'.