China NMPA Product Recall - Medical Image Web Browser Software

GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its medical image web browsing software, specifically the Centricity Universal Viewer Zero Footprint (ZFP) system, on November 8, 2021. The recall was prompted by the discovery of a significant safety issue: when new or modified Image Volumes (image storage devices) are added or changed using Centricity PACS Short-Term Storage, the ZFP software fails to recognize these updates immediately. Consequently, patient examination portions—whether a series or a single image—located on the newly configured storage devices will not be displayed until the ZFP system undergoes a manual restart. This defect could result in healthcare professionals viewing incomplete patient examinations, posing potential risks to accurate diagnosis and patient care. The recall affects medical image web browsing software identified by Registration Certificate Nos.: 20152703014 and 20152213014. This corrective action is being conducted under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration to ensure compliance and mitigate patient safety concerns.