China NMPA Product Recall - Multi-parameter monitor

Nanjing Pu'ao Medical Equipment Co., Ltd. initiated a Class III voluntary recall of its multi-parameter monitors, published by the National Medical Products Administration (NMPA) on January 18, 2019. This action followed non-compliance identified during a 2018 national medical device spot check. The primary issues related to the product's "heart rate measurement range and accuracy, and the suspension or suppression of all physiological and technical alarms." The non-compliance was first reported by the China National Institutes for Food and Drug Control (NIFDC) in October 2018, following testing conducted in May 2018. Despite the company's efforts to communicate its testing methods and request on-site discussion, a non-compliance report was issued. A subsequent re-inspection also confirmed the deficiencies in early December 2018. The recalled unit, model PDJ-3000 (identification 301804511), was a single test sample, not commercially sold, and was located at the Jiangsu Provincial Medical Device Testing Institute. As a required corrective action, the company repaired the original sample, ensured it met qualification standards, and reapplied for retesting of the previously non-compliant parameters to comply with NMPA's regulatory framework.