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 recall was issued for 3 units, with serial numbers 1181, 1188 and 1189, according to the FDA.
No reports of injuries or specific device malfunctions interfering with procedures were mentioned in the FDA filing.
Philips sent urgent field safety notice letters in January to affected customers, identifying the products and indicating that actuators on all affected units would be replaced free of charge.
The company said it will contact all affected customers to discuss implementing the replacements.