China NMPA Product Recall - Medical diagnostic X-ray system

Beijing GE Healthcare Medical Equipment Co., Ltd. has issued a voluntary Class II recall for certain batches of its XR 6000 Medical Diagnostic X-ray Systems, as announced by the National Medical Products Administration (NMPA) on September 14, 2016. This proactive measure follows GE Healthcare's recent identification of a potential safety risk involving the horizontal X-ray tube arm, which could sag or slip during operation. While there have been no reports of serious injuries directly attributed to this issue, the company acknowledges the potential for "extreme events" if the condition is not addressed. The affected systems are intended for general whole-body X-ray imaging and were distributed across various countries, including 117 units sold in China. To mitigate this risk, GE Healthcare is implementing corrective actions that include promptly notifying all affected customers via email. Additionally, the company is deploying its engineers to customer locations to inspect and address the identified issues on the implicated products, ensuring patient safety and product reliability.