China NMPA Product Recall - Image processing software NX 3.0

The National Medical Products Administration (NMPA) published a voluntary Level III recall notice on March 1, 2017, initiated by Agfa Medical Systems (Shanghai) Co., Ltd., regarding their NX3.0 Image Processing Software. The company reported the defect on January 23, 2017. The primary issue identified was a critical software defect causing patient images to be potentially archived in another patient's record under extreme circumstances. This problem is attributed to a memory issue, which also leads to unexpected error warning messages and potential data integrity concerns. The affected product, registered under CFDA (Imported) No. 2013 2702972, is utilized for digital image acquisition, processing, and transmission. Seven demonstration units were impacted across various regions, including Asia, New Zealand, India, Thailand, and Hong Kong. No units had been sold to customers. Agfa Healthcare (Shanghai) Co., Ltd. implemented immediate corrective actions, advising customers to restart their NX workstations daily to prevent memory issues and to restart the system immediately if any warning messages appear. Additionally, the company committed to releasing a new software version, NX 3.0.9000, to provide a permanent solution to these identified problems.