China NMPA Product Recall - Angiography X-ray system

On September 23, 2015, Philips (China) Investment Co., Ltd., acting on behalf of manufacturer Philips Medical Systems Nederland B. V., initiated a voluntary Class III recall for specific models of its Angiography X-ray Systems. The recall impacts eight units of models Allura Xper FD10 722001, 722002, and 722003 that were imported into China. The decision to recall stemmed from customer complaints and internal testing, which identified an embedded software defect. This fault could lead to the failure of the five-minute continuous fluoroscopy reminder sound, a critical safety feature designed to alert operators during prolonged imaging procedures. This operational deficiency represents a non-compliance with established regulatory standards, specifically 21CFR1020.32 (h) (2) (ii) and IEC60601-2-54, Clause 203.6.2.1. C. While no injuries have been reported, the issue presents a potential safety concern. As a corrective measure, Philips is deploying field service engineers to install software version R1.2.9 on all affected Angiography X-ray Systems to rectify the buzzer functionality and ensure compliance with safety requirements.