FDA Device recall Z-0357-2022
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
- FDA Device
- Class II
- ongoing
- Published 2021-12-15
On 2021-12-15 the FDA classified a Class II recall of Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132 by Philips North America, citing 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/detect….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0357-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-11-12 |
| Published | 2021-12-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | US |
Product
Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
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
Identifiers
| code_info | Serial Numbers: As-Maintained System Serial Number 1442 1517 1367 1088 1210 209 422 35 261 692 1468 1469 1470 1471 990…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0357-2022%22
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