China NMPA Product Recall - Medical angiography X-ray system

Philips (China) Investment Co., Ltd., on behalf of Philips Medical Systems Nederland B.V., initiated a voluntary Class II recall of specific Medical Angiography X-ray Systems, with the report submitted to the National Medical Products Administration (NMPA) on February 3, 2015, and publicly announced on February 15, 2015. The recall was prompted by customer feedback indicating that the monitor suspension system collided with the bed surface when lowered to its lowest position. An internal investigation confirmed that the primary issue was an assembly error within the suspension system's transmission mechanism. This malfunction creates a potential safety risk, as it could result in collisions with patients, staff, or adjacent medical equipment. The recall affects various models, including 722003 and 722010, with four units imported and sold in China. As a corrective action, Philips will first dispatch field service engineers to secure the monitor suspension system with straps to prevent accidental falling. Subsequently, once the necessary replacement components are manufactured and supplied, the entire transmission mechanism of the monitor suspension system will be replaced on all affected devices worldwide to ensure safe and proper operation.