China NMPA Product Recall - Medical Angiography X-ray System

On April 12, 2022, Philips Medical Systems Nederland B.V. initiated a voluntary Class II recall of its Medical Angiography X-ray System, as reported by Philips (China) Investment Co., Ltd. The National Medical Products Administration (NMPA) oversees this regulatory action. The recall affects specific product models and batches, including those identified by Medical Device Registration Certificates 20193060314, 20203060323, 20193060319, and 20193060317. The primary issue stems from incomplete data configuration settings within the database of the application and software versions integrated with the system. This critical defect prevents the system from adequately processing X-ray images, thereby compromising its intended diagnostic functionality. The required action by the manufacturer is the immediate voluntary recall of all affected units. Comprehensive details regarding the specific models, specifications, and batch numbers involved are provided in the "Medical Device Recall List" and an accompanying recall event report form.