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

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., representing manufacturer Carestream Health, Inc., issued a voluntary Class II recall for its Digital Medical X-ray Imaging Systems. This action, documented by the National Medical Products Administration (NMPA) on August 8, 2017, addresses a significant safety concern. The core issue involves a risk of the X-ray tube becoming loose from its telescopic arm, potentially leading to separation of the components. An investigation determined that the manufacturing process failed to install four crucial screws required for securing the telescopic arm.

While only one incident of component loosening was reported globally, with no associated personal injuries, Carestream undertook a thorough risk assessment. To uphold user safety, the company decided to initiate the recall. Affected products include the DRXR-1 model, specifically units with serial numbers 800101-800482, encompassing 302 installed units in China, as well as devices worldwide. Carestream's required action involves conducting on-site inspections of all impacted equipment to rectify this manufacturing defect and mitigate any potential safety hazards, demonstrating adherence to medical device regulations.