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 voluntary Class II recall of its Digital Medical X-ray Imaging Systems and Digital Mobile X-ray Machines, as reported by the National Medical Products Administration (NMPA) on July 14, 2017. The recall was prompted by a critical safety concern: the potential for the connection between the X-ray tube and the telescopic arm to loosen, which could result in the complete separation of these components. This issue poses a significant safety risk to users and patients. The affected products include specific batches of X-ray imaging systems and digital mobile X-ray machines, registered under CFDA (Imported) No. 20132304668 and CFDA Import Registration No. 20142305500. Carestream voluntarily undertook this action to address the identified product defect and ensure patient safety. Further details regarding the precise specifications and batches of the impacted devices are available in the company's Medical Device Recall Event Report Form.