Z-0357-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 15, 2021
- Initiation Date
- November 12, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 462 units
Product Description
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Reason for Recall
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
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.
Code Information
Serial Numbers: As-Maintained System Serial Number 1442 1517 1367 1088 1210 209 422 35 261 692 1468 1469 1470 1471 990 1447 578 579 318 103 1067 518 1022 1513 73 548 549 710 711 107 352 539 319 655 1512 2138 1643 1059 36 1058 1647 1201 884 835 836 1613 769 284 232 1253 1254 1255 427 428 429 618 1203 379 705 708 532 706 707 669 1583 1368 1369 88 84 126 971 218 1696 612 133 1770 458 496 1073 1324 982 1756 351 890 1199 1926 1540 1541 642 433 832 1916 776 664 1545 267 1955 1195 432 632 283 2044 1221 1222 187 188 190 919 1121 34 1491 1320 1187 945 540 1041 1440 1049 1050 1051 1052 1053 1614 425 437 1006 1007 1343 517 1497 80 113 257 303 304 305 306 307 2255 1310 668 673 1760 1797 1798 489 629 750 1060 1337 1338 2059 2094 2095 2104 1336 1335 1178 1692 1693 1694 1695 915 1394 974 975 976 977 613 1448 203 1261 611 1732 1737 375 1466 1467 944 1429 716 324 1963 651 972 702 1799 1869 1870 2063 2062 1134 888 519 33 591 610 1645 1683 1893 211 544 219 2121 411 430 641 643 645 652 928 175 174 256 159 806 328 240 620 1057 520 1188 1025 1027 1083 1103 682 987 1644 993 204 205 340 1675 1808 1809 76 77 568 1125 1126 659 1101 1451 1452 943 1120 1985 1136 179 180 181 182 183 184 464 889 1153 1154 1232 1649 1010 962 445 2036 1004 1516 75 1017 1395 1514 858 927 85 1133 462 523 1628 368 980 1008 1009 1054 584 1979 1980 1309 721 724 94 1319 1119 983 485 916 1342 431 901 1021 1026 722 715 1592 1593 254 286 1347 1578 424 136 137 2180 323 216 1747 89 1856 2099 587 592 1190 1860 2199 1861 1828 134 994 448 1615 833 859 396 337 1312 883 886 1068 1960 1311 237 925 926 936 1749 985 1949 1767 1768 657 1533 189 1928 751 871 872 873 874 1211 236 1911 385 386 924 1416 1534 1097 1098 831 1677 370 405 1558 1671 138 1641 718 719 720 68 58 67 69 71 72 903 350 426 2137 434 435 436 409 404 1733 1100 1684 1260 1262 573 1207 1198 736 1189 885 270 262 961 387 388 367 1314 1194 530 1612 215 986 521 378 1122 1868 1065 513 792 1127 74 569 127 128 129 130 402 704 777 1208 1209 654 272 1239 210 265 2208 666 674 277 1702 675 685 688 667 681 703 112 120 1413 1414 1096 1104 1105 671 672 371 515 UDI: (01)00884838058194(21)1442 (01)00884838058194(21)1517 (01)00884838058194(21)1367 (01)00884838058194(21)1088 (01)00884838058194(21)1210 (01)00884838058194(21)209 (01)00884838058194(21)422 (01)00884838058194(21)35 (01)00884838058194(21)261 (01)00884838058194(21)692 (01)00884838058194(21)1468 (01)00884838058194(21)1469 (01)00884838058194(21)1470 (01)00884838058194(21)1471 (01)00884838058194(21)990 (01)00884838058194(21)1447 (01)00884838058194(21)578 (01)00884838058194(21)579 (01)00884838058194(21)318 (01)00884838058194(21)103 (01)00884838058194(21)1067 (01)00884838058194(21)518 (01)00884838058194(21)1022 (01)00884838058194(21)1513 (01)00884838058194(21)73 (01)00884838058194(21)548 (01)00884838058194(21)549 (01)00884838058194(21)710 (01)00884838058194(21)711 (01)00884838058194(21)107 (01)00884838058194(21)352 (01)00884838058194(21)539 (01)00884838058194(21)319 (01)00884838058194(21)655 (01)00884838058194(21)1512 (01)00884838058194(21)2138 (01)00884838058194(21)1643 (01)00884838058194(21)1059 (01)00884838058194(21)36 (01)00884838058194(21)1058 (01)00884838058194(21)1647 (01)00884838058194(21)1201 (01)00884838058194(21)884 (01)00884838058194(21)835 (01)00884838058194(21)836 (01)00884838058194(21)1613 (01)00884838058194(21)769 (01)00884838058194(21)284 (01)00884838058194(21)232 (01)00884838058194(21)1253 (01)00884838058194(21)1254 (01)00884838058194(21)1255 (01)00884838058194(21)427 (01)00884838058194(21)428 (01)00884838058194(21)429 (01)00884838058194(21)618 (01)00884838058194(21)1203 (01)00884838058194(21)379 (01)00884838058194(21)705 (01)00884838058194(21)708 (01)00884838058194(21)532 (01)00884838058194(21)706 (01)00884838058194(21)707 (01)00884838058194(21)669 (01)00884838058194(21)1583 (01)00884838058194(21)1368 (01)00884838058194(21)1369 (01)00884838058194(21)88 (01)00884838058194(21)84 (01)00884838058194(21)126 (01)00884838058194(21)971 (01)00884838058194(21)218 (01)00884838058194(21)1696 (01)00884838058194(21)612 (01)00884838058194(21)133 (01)00884838058194(21)1770 (01)00884838058194(21)458 (01)00884838058194(21)496 (01)00884838058194(21)1073 (01)00884838058194(21)1324 (01)00884838058194(21)982 (01)00884838058194(21)1756 (01)00884838058194(21)351 (01)00884838058194(21)890 (01)00884838058194(21)1199 (01)00884838058194(21)1926 (01)00884838058194(21)1540 (01)00884838058194(21)1541 (01)00884838058194(21)642 (01)00884838058194(21)433 (01)00884838058194(21)832 (01)00884838058194(21)1916 (01)00884838058194(21)776 (01)00884838058194(21)664 (01)00884838058194(21)1545 (01)00884838058194(21)267 (01)00884838058194(21)1955 (01)00884838058194(21)1195 (01)00884838058194(21)432 (01)00884838058194(21)632 (01)00884838058194(21)283 (01)00884838058194(21)2044 (01)00884838058194(21)1221 (01)00884838058194(21)1222 (01)00884838058194(21)187 (01)00884838058194(21)188 (01)00884838058194(21)190 (01)00884838058194(21)919 (01)00884838058194(21)1121 (01)00884838058194(21)34 (01)00884838058194(21)1491 (01)00884838058194(21)1320 (01)00884838058194(21)1187 (01)00884838058194(21)945 (01)00884838058194(21)540 (01)00884838058194(21)1041 (01)00884838058194(21)1440 (01)00884838058194(21)1049 (01)00884838058194(21)1050 (01)00884838058194(21)1051 (01)00884838058194(21)1052 (01)00884838058194(21)1053 (01)00884838058194(21)1614 (01)00884838058194(21)425 (01)00884838058194(21)437 (01)00884838058194(21)1006 (01)00884838058194(21)1007 (01)00884838058194(21)1343 (01)00884838058194(21)517 (01)00884838058194(21)1497 (01)00884838058194(21)80 (01)00884838058194(21)113 (01)00884838058194(21)257 (01)00884838058194(21)303 (01)00884838058194(21)304 (01)00884838058194(21)305 (01)00884838058194(21)306 (01)00884838058194(21)307 (01)00884838058194(21)2255 (01)00884838058194(21)1310 (01)00884838058194(21)668 (01)00884838058194(21)673 (01)00884838058194(21)1760 (01)00884838058194(21)1797 (01)00884838058194(21)1798 (01)00884838058194(21)489 (01)00884838058194(21)629 (01)00884838058194(21)750 (01)00884838058194(21)1060 (01)00884838058194(21)1337 (01)00884838058194(21)1338 (01)00884838058194(21)2059 (01)00884838058194(21)2094 (01)00884838058194(21)2095 (01)00884838058194(21)2104 (01)00884838058194(21)1336 (01)00884838058194(21)1335 (01)00884838058194(21)1178 (01)00884838058194(21)1692 (01)00884838058194(21)1693 (01)00884838058194(21)1694 (01)00884838058194(21)1695 (01)00884838058194(21)915 (01)00884838058194(21)1394 (01)00884838058194(21)974 (01)00884838058194(21)975 (01)00884838058194(21)976 (01)00884838058194(21)977 (01)00884838058194(21)613 (01)00884838058194(21)1448 (01)00884838058194(21)203 (01)00884838058194(21)1261 (01)00884838058194(21)611 (01)00884838058194(21)1732 (01)00884838058194(21)1737 (01)00884838058194(21)375 (01)00884838058194(21)1466 (01)00884838058194(21)1467 (01)00884838058194(21)944 (01)00884838058194(21)1429 (01)00884838058194(21)716 (01)00884838058194(21)324 (01)00884838058194(21)1963 (01)00884838058194(21)651 (01)00884838058194(21)972 (01)00884838058194(21)702 (01)00884838058194(21)1799 (01)00884838058194(21)1869 (01)00884838058194(21)1870 (01)00884838058194(21)2063 (01)00884838058194(21)2062 (01)00884838058194(21)1134 (01)00884838058194(21)888 (01)00884838058194(21)519 (01)00884838058194(21)33 (01)00884838058194(21)591 (01)00884838058194(21)610 (01)00884838058194(21)1645 (01)00884838058194(21)1683 (01)00884838058194(21)1893 (01)00884838058194(21)211 (01)00884838058194(21)544 (01)00884838058194(21)219 (01)00884838058194(21)2121 (01)00884838058194(21)411 (01)00884838058194(21)430 (01)00884838058194(21)641 (01)00884838058194(21)643 (01)00884838058194(21)645 (01)00884838058194(21)652 (01)00884838058194(21)928 (01)00884838058194(21)175 (01)00884838058194(21)174 (01)00884838058194(21)256 (01)00884838058194(21)159 (01)00884838058194(21)806 (01)00884838058194(21)328 (01)00884838058194(21)240 (01)00884838058194(21)620 (01)00884838058194(21)1057 (01)00884838058194(21)520 (01)00884838058194(21)1188 (01)00884838058194(21)1025 (01)00884838058194(21)1027 (01)00884838058194(21)1083 (01)00884838058194(21)1103 (01)00884838058194(21)682 (01)00884838058194(21)987 (01)00884838058194(21)1644 (01)00884838058194(21)993 (01)00884838058194(21)204 (01)00884838058194(21)205 (01)00884838058194(21)340 (01)00884838058194(21)1675 (01)00884838058194(21)1808 (01)00884838058194(21)1809 (01)00884838058194(21)76 (01)00884838058194(21)77 (01)00884838058194(21)568 (01)00884838058194(21)1125 (01)00884838058194(21)1126 (01)00884838058194(21)659 (01)00884838058194(21)1101 (01)00884838058194(21)1451 (01)00884838058194(21)1452 (01)00884838058194(21)943 (01)00884838058194(21)1120 (01)00884838058194(21)1985 (01)00884838058194(21)1136 (01)00884838058194(21)179 (01)00884838058194(21)180 (01)00884838058194(21)181 (01)00884838058194(21)182 (01)00884838058194(21)183 (01)00884838058194(21)184 (01)00884838058194(21)464 (01)00884838058194(21)889 (01)00884838058194(21)1153 (01)00884838058194(21)1154 (01)00884838058194(21)1232 (01)00884838058194(21)1649 (01)00884838058194(21)1010 (01)00884838058194(21)962 (01)00884838058194(21)445 (01)00884838058194(21)2036 (01)00884838058194(21)1004 (01)00884838058194(21)1516 (01)00884838058194(21)75 (01)00884838058194(21)1017 (01)00884838058194(21)1395 (01)00884838058194(21)1514 (01)00884838058194(21)858 (01)00884838058194(21)927 (01)00884838058194(21)85 (01)00884838058194(21)1133 (01)00884838058194(21)462 (01)00884838058194(21)523 (01)00884838058194(21)1628 (01)00884838058194(21)368 (01)00884838058194(21)980 (01)00884838058194(21)1008 (01)00884838058194(21)1009 (01)00884838058194(21)1054 (01)00884838058194(21)584 (01)00884838058194(21)1979 (01)00884838058194(21)1980 (01)00884838058194(21)1309 (01)00884838058194(21)721 (01)00884838058194(21)724 (01)00884838058194(21)94 (01)00884838058194(21)1319 (01)00884838058194(21)1119 (01)00884838058194(21)983 (01)00884838058194(21)485 (01)00884838058194(21)916 (01)00884838058194(21)1342 (01)00884838058194(21)431 (01)00884838058194(21)901 (01)00884838058194(21)1021 (01)00884838058194(21)1026 (01)00884838058194(21)722 (01)00884838058194(21)715 (01)00884838058194(21)1592 (01)00884838058194(21)1593 (01)00884838058194(21)254 (01)00884838058194(21)286 (01)00884838058194(21)1347 (01)00884838058194(21)1578 (01)00884838058194(21)424 (01)00884838058194(21)136 (01)00884838058194(21)137 (01)00884838058194(21)2180 (01)00884838058194(21)323 (01)00884838058194(21)216 (01)00884838058194(21)1747 (01)00884838058194(21)89 (01)00884838058194(21)1856 (01)00884838058194(21)2099 (01)00884838058194(21)587 (01)00884838058194(21)592 (01)00884838058194(21)1190 (01)00884838058194(21)1860 (01)00884838058194(21)2199 (01)00884838058194(21)1861 (01)00884838058194(21)1828 (01)00884838058194(21)134 (01)00884838058194(21)994 (01)00884838058194(21)448 (01)00884838058194(21)1615 (01)00884838058194(21)833 (01)00884838058194(21)859 (01)00884838058194(21)396 (01)00884838058194(21)337 (01)00884838058194(21)1312 (01)00884838058194(21)883 (01)00884838058194(21)886 (01)00884838058194(21)1068 (01)00884838058194(21)1960 (01)00884838058194(21)1311 (01)00884838058194(21)237 (01)00884838058194(21)925 (01)00884838058194(21)926 (01)00884838058194(21)936 (01)00884838058194(21)1749 (01)00884838058194(21)985 (01)00884838058194(21)1949 (01)00884838058194(21)1767 (01)00884838058194(21)1768 (01)00884838058194(21)657 (01)00884838058194(21)1533 (01)00884838058194(21)189 (01)00884838058194(21)1928 (01)00884838058194(21)751 (01)00884838058194(21)871 (01)00884838058194(21)872 (01)00884838058194(21)873 (01)00884838058194(21)874 (01)00884838058194(21)1211 (01)00884838058194(21)236 (01)00884838058194(21)1911 (01)00884838058194(21)385 (01)00884838058194(21)386 (01)00884838058194(21)924 (01)00884838058194(21)1416 (01)00884838058194(21)1534 (01)00884838058194(21)1097 (01)00884838058194(21)1098 (01)00884838058194(21)831 (01)00884838058194(21)1677 (01)00884838058194(21)370 (01)00884838058194(21)405 (01)00884838058194(21)1558 (01)00884838058194(21)1671 (01)00884838058194(21)138 (01)00884838058194(21)1641 (01)00884838058194(21)718 (01)00884838058194(21)719 (01)00884838058194(21)720 (01)00884838058194(21)68 (01)00884838058194(21)58 (01)00884838058194(21)67 (01)00884838058194(21)69 (01)00884838058194(21)71 (01)00884838058194(21)72 (01)00884838058194(21)903 (01)00884838058194(21)350 (01)00884838058194(21)426 (01)00884838058194(21)2137 (01)00884838058194(21)434 (01)00884838058194(21)435 (01)00884838058194(21)436 (01)00884838058194(21)409 (01)00884838058194(21)404 (01)00884838058194(21)1733 (01)00884838058194(21)1100 (01)00884838058194(21)1684 (01)00884838058194(21)1260 (01)00884838058194(21)1262 (01)00884838058194(21)573 (01)00884838058194(21)1207 (01)00884838058194(21)1198 (01)00884838058194(21)736 (01)00884838058194(21)1189 (01)00884838058194(21)885 (01)00884838058194(21)270 (01)00884838058194(21)262 (01)00884838058194(21)961 (01)00884838058194(21)387 (01)00884838058194(21)388 (01)00884838058194(21)367 (01)00884838058194(21)1314 (01)00884838058194(21)1194 (01)00884838058194(21)530 (01)00884838058194(21)1612 (01)00884838058194(21)215 (01)00884838058194(21)986 (01)00884838058194(21)521 (01)00884838058194(21)378 (01)00884838058194(21)1122 (01)00884838058194(21)1868 (01)00884838058194(21)1065 (01)00884838058194(21)513 (01)00884838058194(21)792 (01)00884838058194(21)1127 (01)00884838058194(21)74 (01)00884838058194(21)569 (01)00884838058194(21)127 (01)00884838058194(21)128 (01)00884838058194(21)129 (01)00884838058194(21)130 (01)00884838058194(21)402 (01)00884838058194(21)704 (01)00884838058194(21)777 (01)00884838058194(21)1208 (01)00884838058194(21)1209 (01)00884838058194(21)654 (01)00884838058194(21)272 (01)00884838058194(21)1239 (01)00884838058194(21)210 (01)00884838058194(21)265 (01)00884838058194(21)2208 (01)00884838058194(21)666 (01)00884838058194(21)674 (01)00884838058194(21)277 (01)00884838058194(21)1702 (01)00884838058194(21)675 (01)00884838058194(21)685 (01)00884838058194(21)688 (01)00884838058194(21)667 (01)00884838058194(21)681 (01)00884838058194(21)703 (01)00884838058194(21)112 (01)00884838058194(21)120 (01)00884838058194(21)1413 (01)00884838058194(21)1414 (01)00884838058194(21)1096 (01)00884838058194(21)1104 (01)00884838058194(21)1105 (01)00884838058194(21)671 (01)00884838058194(21)672 (01)00884838058194(21)371 (01)00884838058194(21)515