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

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. initiated a Class II voluntary recall on August 8, 2017, for specific models of its digital medical X-ray imaging systems, including mobile X-ray machines. The recall was prompted by the discovery of a critical manufacturing defect: an insufficient connection between the X-ray tube and its telescopic arm. An investigation revealed that affected devices lacked the four essential screws required to secure the telescopic arm according to established manufacturing procedures. This significant issue poses a risk of the X-ray tube separating from the arm, although only one incident, without personal injury, had been reported globally at the time of the recall. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), previously the CFDA, Carestream is committed to ensuring product safety. As a corrective action, the company is conducting on-site inspections of all potentially affected units to identify and rectify this safety hazard comprehensively. This proactive measure aims to prevent any potential risks to users and ensure the proper functioning of their medical imaging equipment.