China NMPA Product Recall - Allura Xper angiography X-ray system

Philips (China) Investment Co., Ltd., on behalf of its manufacturer Philips Medical Systems Nederland B.V., initiated a voluntary Class II recall of its Angiography X-ray Systems. The recall was formally reported by Philips on February 15, 2015, and publicly announced by the National Medical Products Administration (NMPA) on March 10, 2015. The primary issue identified was a software error that caused the system's buzzer to fail to sound after five minutes of fluoroscopy. This audible signal is essential for preventing patients from receiving unnecessary radiation during medical procedures. While no patient injuries have been reported, the malfunction poses a risk of increased radiation exposure. The affected products include various Allura Xper models, with 141 units imported into China as part of a global recall. Under the NMPA's regulatory framework, Philips is implementing a corrective action. Field service engineers will update the affected devices by installing software version R7.2.8 to rectify the buzzer malfunction and ensure proper patient safety protocols are maintained.