China NMPA Product Recall - Angiography X-ray system

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its Angiography X-ray Systems, manufactured by Philips Medical Systems Nederland B. V., with the report submitted to the National Medical Products Administration (NMPA) on November 20, 2015, and publicly announced on December 15, 2015. The recall affects 703 units worldwide, encompassing models such as Allura Xper, Allura CV, and Allura Centron. The primary concern is a software malfunction that, under specific operating conditions, causes the 5-minute fluorescent audible signal to fail to produce sound. This issue represents a non-compliance with critical regulatory standards, including sections of 21CFR1020.32(h)(2)(ii) and IEC60601-2-54, Clause 203.6.2.1.c, which govern the safety and performance of X-ray equipment. Philips has confirmed that no patient injuries have been attributed to this specific defect. To address the problem, the company's required actions include notifying all impacted users through on-site safety communications. Furthermore, commencing December 2015, Philips field service engineers were mandated to implement a software update designed to permanently resolve the audible signal issue, ensuring device compliance and patient safety.