FDA Slaps a Class II Recall on Three of Royal Philips Electronics N.V.'s Allura Xper Vascular X-ray Systems
The FDA yesterday published a Class II recall notice for a select number of Royal Philips (NYSE:PHG) Integris Allura Xper vascular system, designed for vascular x-ray imaging applications over issues with its monitor ceiling suspension system failing.
The Integris Allura Xper system is designed for cardiovascular and vascular X-ray imaging applications as well as interventional procedures such as percutaneous transluminal coronary angioplasties, stent placements, embolizations, pacemaker implantations and electrophysiology.
The system is specifically designed for ‘hybrid’ rooms, and use of the platform in operating rooms is restricted, according to the federal watchdog.
The Integris Allura Xper system is designed for cardiovascular and vascular X-ray imaging applications as well as interventional procedures such as percutaneous transluminal coronary angioplasties, stent placements, embolizations, pacemaker implantations and electrophysiology.
The system is specifically designed for ‘hybrid’ rooms, and use of the platform in operating rooms is restricted, according to the federal watchdog.