China NMPA Product Recall - Digital medical X-ray imaging system; Digital mobile X-ray machine

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., acting as the agent for manufacturer Carestream Health, Inc., initiated a voluntary Class II recall for its Digital Medical X-ray Imaging Systems and Digital Mobile X-ray Machines. This recall, reported on July 19, 2017, addresses a significant safety issue: the risk of the X-ray tube connection to the telescopic arm becoming loose, potentially leading to separation. An investigation revealed that the telescopic arm of affected devices, including Model DRXR-1 (serial numbers 800101-800482, impacting 302 units in China), lacked the four essential securing screws, a deviation from manufacturing procedures. Although only one incident has been identified globally with no reported injuries, the company conducted a thorough risk assessment. Under the regulatory oversight of China's National Medical Products Administration (NMPA), Carestream is now conducting on-site inspections of all potentially affected equipment to proactively identify and rectify any manufacturing deficiencies, ensuring user safety and product integrity. The recall applies to devices registered under CFDA Import Registration Certificates No. 20132304668 and 20142305500.