China NMPA Product Recall - Mobile C-arm X-ray machine

Beijing GE Healthcare Co., Ltd. initiated a voluntary Class II recall for its mobile C-arm X-ray machines, specifically models Brivo OEC 715 and Brivo OEC 785. The recall was publicly announced by the National Medical Products Administration (NMPA) on September 29, 2016, following the company's report on September 22, 2016. The primary concern stems from a potential malfunction in the circuit board responsible for controlling the C-arm's movement. This defect could lead to unexpected or uncontrolled motion of the C-arm during surgical procedures, posing a risk of collision with other medical equipment or causing soft tissue injury to patients. Fortunately, no injuries related to this issue have been reported to date. Under the NMPA's regulatory guidance, Beijing GE Healthcare's required actions include recalling the affected product batches. Furthermore, the company is implementing corrective measures by distributing emails to all customers to inform them about the identified safety concern and provide comprehensive guidance on the safe operation of the mobile C-arm X-ray machines, aiming to mitigate any potential risks and ensure patient safety.