Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079

Recall details

Manufacturer

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Distributor

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Palestine, State of Peru, Philippines, Poland, Portugal, R¿union Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.

Lot

Model /UDI-DI: (1) 722063 (01)00884838085275(21); (2) 722064 (01)00884838085282(21); (3) 722067 (01)00884838085350(21); (4) 722068 (01)00884838085367(21); (5) 722078 (01)00884838085251(21); (6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2

Risk classification

Class II

Area (FDA)

device

Country

Netherlands