China NMPA Product Recall - Multi-parameter monitor

Shenzhen Weihaokang Medical Device Co., Ltd. voluntarily initiated a Level II recall for its multi-parameter patient monitors, model Angel-6000H, as reported to the National Medical Products Administration (NMPA) on December 6, 2018. The recall stemmed from identified product non-conformities during testing, which revealed two critical issues. Firstly, the neonatal/pediatric heart rate measurement range, although compliant with the YY1079-2008 standard, did not meet the product's specific technical requirements, potentially leading to inaccurate readings when exceeding the instrument's specified range. Secondly, the selection function for pausing or suppressing operations lacked proper encryption. To address these violations, the company promptly issued a warning to its sales department, requesting the return of the two affected trial units (WA0406HE0001 and WA0606ID0001). Corrective actions include a software upgrade to synchronize the heart rate measurement range with the product's technical specifications and the implementation of encryption for the "Alarm Setting Disable" feature within the manufacturer's settings. This recall ensures compliance with the medical device regulatory framework overseen by the NMPA in China.