China NMPA Product Recall - Medical diagnostic rotating anode X-ray tube assembly

On August 8, 2022, Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Level III recall, as announced by the National Medical Products Administration (NMPA) and reported by the Jiangsu Provincial Drug Administration. The recall pertains to Medical Diagnostic Rotating Anode X-ray Tube Assemblies, specifically models "DA200ULTRA" and "DA135". The core issue identified was a labeling discrepancy: an incorrect registration certificate number was printed within the X-ray tube operator's manual (IFU). Philips Medical emphasizes that this error does not compromise the clinical functionality or safety of the devices, and no related complaints have been reported. This proactive measure falls under the regulatory oversight of the NMPA, which categorizes it as a Level III recall, indicating a low probability of adverse health consequences. The company's required action involves notifying affected device users, particularly those with FCO78100547 X-ray tubes, about the correct X-ray tube replacement procedure, implicitly addressing the manual's inaccuracy. This voluntary recall underscores Philips Medical's adherence to documentation accuracy and regulatory standards within the medical device industry.