China NMPA Product Recall - Digital medical X-ray imaging system

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., on August 13, 2015, initiated a Class II voluntary recall of its Digital Medical X-ray Imaging Systems, specifically DRX-Evolution systems utilizing software versions V5.6 or V5.7. This action was reported to the National Medical Products Administration (NMPA). The recall stemmed from a discovered issue where the "Auto Stitching" function, used for generating ultra-long composite images, could produce alignment errors that the software failed to recognize. This occurred when external reference markers or measurement tools were not employed, and technicians relied solely on the automatic stitching feature. The company noted that these errors could, however, be identified and rectified through the "Manual Stitching" option.

To address this critical product issue affecting 14 countries and regions, Carestream implemented a multi-step corrective action plan. Customers were directly informed of the defect. Subsequently, the company's service personnel, Rayco, committed to conducting on-site inspections of the affected equipment. A free software upgrade package was to be installed to permanently resolve the stitching malfunction. In the interim, Carestream advised users to temporarily disable the problematic "Automatic Stitching" function and instead utilize the "Manual Stitching" editor for creating and compositing ultra-long images until the software upgrade installation was completed. This proactive recall aimed to ensure the accuracy and reliability of diagnostic imaging.