China NMPA Product Recall - Kodak DR7500 Digital Radiography System, Digital Medical X-ray Imaging System

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd. has initiated a voluntary Class II recall for its Kodak DR7500 Digital Radiography System and a Digital Medical X-ray Imaging System. This action, publicly announced by the National Medical Products Administration (NMPA) on December 5, 2018, addresses a potential safety hazard identified during on-site maintenance. The main issue involves the suspended frame of the product, where a risk of wire rope breakage exists. Should the wire rope fail, the suspension components could collide with the ceiling, posing a significant injury risk to both users and patients. The recall is being conducted under the regulatory oversight of the NMPA and was reported through the Shanghai Food and Drug Administration's medical device recall system (Index No. JGXX-2018-11397, Shanghai Food and Drug Administration Medical Device Recall 2018-280). Carestream's required action is a voluntary Class II recall, indicating a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This proactive measure aims to mitigate the identified safety risks and ensure the continued safety and reliability of their medical devices. Further specifics on affected models are available in the attached "Medical Device Recall Event Report Form."