China NMPA Product Recall - Angiography X-ray system

Philips (China) Investment Co., Ltd., in conjunction with its manufacturing entity, Philips Medical Systems Nederland B. V., initiated a voluntary Level III recall of its Angiography X-ray Systems (Model Allura Xper FD20, 722006). This action, reported internally on October 28, 2015, and publicly announced by the National Medical Products Administration (NMPA) on November 19, 2015, stemmed from the discovery of intermittent electronic malfunctions identified through customer complaints and internal testing. The core issue was a software error that could prevent the 5-minute fluoroscopy warning signal from emitting an audible alert. This critical safety failure constitutes non-compliance with regulatory standards, specifically 21CFR 1020.32 (h)(2)(ii) and IEC 60601-2-54, Clause 203.6.2.1c. While no injuries have been reported, the recall impacts 20 units imported and sold in China, as part of a broader global recall effort. To rectify the defect, Philips is deploying field service engineers to install software version R2.x on all affected devices, ensuring the proper functionality of the audible fluoroscopy warning signal.