Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
Check against the official notice below — it lists the full affected range.
Philips North America is recalling 462 units of the Veradius Unity with Software Release 2.1, a mobile diagnostic X-ray imaging and viewing system (Model 718132). The Instructions for Use do not specify the maximum surface temperature of the X-ray tank—which houses the X-ray tube, beam filter, and cooling oil—or the image intensifier/detector. This omission creates a hazard of burns to users or patients who may come into contact with these components during operation.
The recalled units have been distributed worldwide, including throughout the United States and 89 other countries. The record identifies 462 specific system serial numbers affected by this recall. However, the source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 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 G Quantity: 462 units Lot/code info: 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 44
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.