China NMPA Product Recall - Central workstation

GE Medical Systems Information Technologies, Inc., through its distributor GE Medical Systems Trade Development (Shanghai) Co., Ltd., initiated a voluntary recall for certain Central Workstations (NMPA Registration Certificate No.: 20142215843). This action, reported to the National Medical Products Administration (NMPA) on January 26, 2016, and published on February 25, 2016, stems from a critical manufacturing defect in the integrated PRN50-M- recorders, supplied by GSI Group Company (JADAK Division).

The main issue is that these recorders did not meet the expected design requirements for flame retardancy and liquid ingress protection. This non-conformance posed an increased risk of users and/or patients being exposed to sparks and/or electric shock. Despite the severity of the flaw, the recall document explicitly states that none of the affected products were sold or distributed within China. Consequently, the primary action is the manufacturer's voluntary recall, with the NMPA requesting that all provincial drug administrations strengthen their supervision and management of similar medical devices to prevent future occurrences of such safety issues, even if the direct impact on the Chinese market was mitigated.