BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075

Reason: Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns

Code information: Serial Number: 173 105 5301 4950 5360 4651 4891 873 1633 160 543 562 204 5090 5091 5092 4840 5073 125 383 384 5121 UDI: (01)00884838055490(21)173 (01)00884838055490(21)105 (01)00884838055490(21)5301 (01)00884838055490(21)4950 (01)00884838055490(21)5360 (01)00884838055490(21)4651 (01)00884838055490(21)4891 (01)00884838055490(21)873 (01)00884838055490(21)1633 (01)00884838055490(21)160 (01)00884838055490(21)543 (01)00884838055490(21)562 (01)00884838055490(21)204 (01)00884838055490(21)5090 (01)00884838055490(21)5091 (01)00884838055490(21)5092 (01)00884838055490(21)4840 (01)00884838055490(21)5073 (01)00884838055490(21)125 (01)00884838055490(21)383 (01)00884838055490(21)384 (01)00884838055490(21)5121

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Afghanistan, Algeria, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cameroon, Chile, China, Colombia, Cook Islands, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Faroe Islands, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives Mali, Martinique, Mauritius, Mexico, Moldova, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, Zimbabwe.