China NMPA Product Recall - Angiography X-ray system

Philips (China) Investment Co., Ltd. initiated a voluntary global recall of its Angiography X-ray Systems, including Allura Xper, Allura CV, and Allura Centron models, as reported to the National Medical Products Administration (NMPA) on December 15, 2015. The recall addresses a critical safety concern where, under specific conditions, the system could lead to the misinterpretation of static images as dynamic images during X-ray imaging for clinical vascular and cardiovascular interventional procedures. This issue affects 871 units globally, with 817 units already sold. Under the regulatory oversight of the NMPA (formerly CFDA), Philips Medical Systems Nederland B. V. is the manufacturer, with Philips (China) managing the recall process. The primary violation identified is this potential image misinterpretation. As part of the required corrective actions, Philips will issue a Field Safety Notification (FSN) to all affected users. This notification will remind users to strictly adhere to the Instructions for Use (IFU). Specific actions include ensuring that the system displays both motion and still image prompts, maintaining the X-ray buzzer in an 'always-on' state, activating only one X-ray pedal at any given time, and configuring the foot switch to the default Philips settings. These measures aim to mitigate the risk of misdiagnosis and enhance patient safety.