Device Recall Allura Xper Philips Xray Systems

Allura Xper systems - Model #'s 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722078, 722079, (added as of 6/25/2018) 1120

Radiology Devices

2

No

Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.

Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. || Product Usage: || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.