China NMPA Product Recall - Fully automated sample processing system

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd., in coordination with Siemens Healthcare Diagnostics Inc., initiated a voluntary recall of its Fully Automated Sample Processing System, classified as Class III by the National Medical Products Administration (NMPA), and reported on December 7, 2016. The recall stems from a critical safety concern identified by a supplier: specific power cable plugs, which connect to the automation system's refrigerated storage and centrifuge modules, have the potential to overheat, creating an electrical hazard. This issue affects various models of Refrigerated Storage Modules (e.g., 10703049, 10715227) and Centrifuge Modules (e.g., 10703032, 10713761) that have been shipped since May 21, 2014. A total of 106 units were imported or sold in China. Under the NMPA's regulatory oversight, Siemens Healthcare is undertaking two primary corrective actions: first, issuing immediate customer letters to all affected clients; and second, deploying Siemens customer service engineers to directly replace the identified faulty power cables for the affected systems.