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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89129

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 12, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Philips North America Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-0355-2022
Recall number
Z-0355-2022
Initiated
November 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
22 units US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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.

device · product 2 of 3

BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

Z-0356-2022
Recall number
Z-0356-2022
Initiated
November 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
1201 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

serial Numbers: 2368 257 252 1234 1139 1989 12662 604 1858 4196 2046 1826 312 313 1360 2438 802 844 1620 3007 2348 318 303 2737 2739 1197 2564 983 236 481 1983 386 13027 74 75 589 693 154 2735 13242 377 798 4466 687 77 565 1101 112 2836 2837 1703 13006 13014 2427 12954 1982 4740 13796 13795 561 13823 13824 597 671 1089 113 1732 13156 1866 2423 1427 325 108 3721 3189 326 3093 603 622 924 282 1984 1152 3009 1059 1136 981 2342 2666 196 73 1650 793 794 799 800 444 3857 289 2866 2020 1138 1547 1548 2708 13604 415 548 3186 2409 2760 3485 3487 2012 48 1869 50 927 193 351 383 384 2811 2821 1885 12566 1937 2365 2810 3078 12618 12619 12620 12621 12622 12623 12624 12625 12626 12628 4080 13051 3534 3301 2279 2385 194 609 52 2185 2311 2366 2177 1461 488 489 492 13519 3568 4758 4759 130 398 3760 2978 3594 1609 1709 2284 4475 285 4390 740 485 2430 38 635 1938 117 13810 3513 13 951 13456 12495 1140 2095 639 1990 2300 1448 897 577 1820 378 259 4381 1744 1745 1746 3512 505 2707 2888 2706 40 1575 2644 2281 1378 2807 1376 12692 1956 535 12895 1148 1987 570 641 366 1438 2526 177 15 2397 1986 3516 2606 644 1734 1735 381 3103 102 514 1085 2003 13402 30 278 1030 1831 139 1586 1567 431 1478 402 806 3058 3962 3963 2266 2227 13326 4022 1487 2338 4094 306 4380 1608 152 12678 3079 591 13394 35 2411 550 2915 1818 121 2704 13072 1048 4320 1677 4137 103 104 111 3190 987 988 2679 64 2410 182 227 2216 92 484 475 1660 1291 58 2465 2843 82 424 2111 13634 2126 1463 2194 2897 2898 2899 2900 2901 1981 1474 2424 1488 1736 1537 2075 3005 437 1797 2819 2437 2822 2431 3632 13312 3495 655 719 33 54 304 307 309 12651 652 879 933 1509 1079 1741 1742 1726 1727 3527 1037 2436 2926 2927 12778 893 2336 886 2282 810 1417 1201 1558 2444 2485 744 273 1049 1424 2667 2668 2169 68 3195 645 62 545 12744 219 2280 766 13381 69 70 623 657 1185 3451 619 1055 213 792 590 12529 12706 684 1470 389 551 1783 3273 3274 1018 3128 564 242 243 938 504 513 1067 3199 411 61 352 12966 1455 926 2025 2617 4077 4772 263 264 265 266 267 268 269 270 271 272 441 3761 56 739 2473 3381 694 809 625 324 1038 13714 13717 2736 1497 867 12701 76 13214 12579 901 1161 2418 2525 612 1361 1363 2448 677 479 405 818 4778 1968 2570 2575 12548 42 1606 1607 1967 2341 3519 3520 3557 4742 4757 2016 669 3469 1221 293 3514 292 471 287 1647 1574 1026 1027 1028 109 2571 2572 365 1743 12707 1529 2203 3539 1340 2120 2121 1135 12474 13398 13116 1657 1091 3442 13071 1192 2559 2786 508 1471 1634 539 4470 291 1147 13581 12642 470 32 211 89 90 2432 895 2441 1506 200 1131 1476 13112 12429 971 2527 12567 12859 13007 2118 2119 2565 2860 986 1663 782 2022 3213 3196 72 418 2168 1865 3086 795 2183 2064 1496 1102 796 797 1422 3209 4090 4091 4092 1472 3730 2561 2931 1256 2440 1648 1483 2566 244 245 246 875 235 13062 2562 1029 541 256 1259 1615 1872 2358 2834 115 3101 3090 4615 464 465 990 804 349 1477 1479 201 238 41 1416 3504 1966 825 878 2916 2611 1946 1597 2097 3238 2135 1848 480 1546 3191 3731 12702 13636 12987 447 2635 2636 100 191 1041 1132 2187 159 741 923 977 4391 826 1527 2832 3517 374 3370 3375 1480 3327 4613 4614 223 44 3411 3092 1991 13243 2923 221 12953 440 31 691 726 392 2919 529 1536 26 718 13307 2689 4103 3515 824 391 1898 582 820 1903 210 116 747 887 1033 1065 646 49 3855 1523 1999 1998 4373 2000 991 1250 2744 1356 2246 4423 4424 1731 2455 91 379 320 311 2277 3319 12801 2477 251 1130 1988 1588 1589 1590 616 1572 209 640 99 34 39 801 3968 1635 1979 43 2863 654 13829 66 3664 1827 2429 3184 414 605 663 664 665 413 662 13505 647 1429 769 2484 542 543 4227 1323 1970 357 358 3210 2865 1965 1220 416 1992 1475 408 1857 348 982 1819 319 2958 3134 12501 2099 3392 37 12900 178 3069 1032 1305 1894 403 1141 1142 3076 4751 4756 3109 1530 1868 1423 4569 13209 2818 12603 4727 4728 4729 4730 2702 4078 1980 928 929 930 931 932 2703 12975 1362 2349 2350 902 3088 1528 249 2612 487 1058 13665 13628 2820 1921 827 686 2042 1226 1306 1659 1661 3856 626 627 2766 2767 660 29 12969 12790 13549 2844 3424 13462 1364 2993 2994 65 2823 2043 1390 2713 2714 13751 852 853 13476 1070 3986 2548 816 137 410 859 2867 1016 1656 2110 2435 2917 13257 13258 284 218 2204 2231 1682 1900 1193 746 87 2541 3486 247 248 624 1108 350 169 610 474 355 356 894 295 300 220 2128 67 1712 2259 3944 150 898 717 860 1017 2959 4345 190 1377 2618 2425 659 138 1156 13203 13477 1298 1258 2094 168 167 317 1662 217 12681 2443 1936 2573 3102 195 134 135 682 2759 3892 3121 1203 3398 1758 13707 1784 12454 515 2271 250 721 478 57 2747 1425 750 2588 621 934 1066 1605 1658 2186 3187 3237 3239 12923 12924 985 1603 4239 4240 13212 12463 3418 4528 4529 3744 4264 126 3087 892 1307 668 3802 2439 4616 12922 13779 13026 13029 13496 13025 2549 13538 13539 3573 13028 733 12650 1685 1959 3584 3661 3663 4706 12466 13032 13498 3662 13030 13033 690 2722 1681 1526 3091 13530 141 142 143 148 149 1598 1599 1600 1601 12904 706 12766 705 707 688 1420 1421 2491 2557 2558 2560 2005 2018 521 4212 4213 12990 12991 1654 1655 2225 2226 2670 1260 2041 614 321 2044 1922 2127 1251 128 180 2428 2433 704 2469 4770 658 728 2421 2426 12690 1129 1447 1931 421 1145 1616 576 1240 4114 1482 395 534 562 3540 3619 533 544 634 1498 2614 1133 60 1919 670 13038 2434 1308 1359 12634 2442 2486 2021 2738 260 1198 13344 482 12 2716 3476 2247 222 1186 643 2563 1481 390 407 13742 1510 2130 1485 2528 224 1649 2253 1713 1462 120 2047 11 388 12522 3242 17 327 642 903 692 745 498 2711 1430 3089 472 427 425 3711 228 720 429 2073 2074 2924 207 78 114 3240 286 1187 950 13353 277 322 1679 3943 12647 129 428 1383 1531 140 854 3297 758 208 620 922 93 155 290 2918 240 1568 3293 3294 2697 791 1710 1908 783 784 2943 2178 1418 1419 1711 179 689 151 153 342 458 UDI: As-Maintained System Unique Device Identifier (UDI#) (01)00884838055506(21)2368 (01)00884838055506(21)257 (01)00884838055506(21)252 (01)00884838055506(21)1234 (01)00884838055506(21)1139 (01)00884838055506(21)1989 (01)00884838055506(21)12662 (01)00884838055506(21)604 (01)00884838055506(21)1858 (01)00884838055506(21)4196 (01)00884838055506(21)2046 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(01)00884838055506(21)2836 (01)00884838055506(21)2837 (01)00884838055506(21)1703 (01)00884838055506(21)13006 (01)00884838055506(21)13014 (01)00884838055506(21)2427 (01)00884838055506(21)12954 (01)00884838055506(21)1982 (01)00884838055506(21)4740 (01)00884838055506(21)13796 (01)00884838055506(21)13795 (01)00884838055506(21)561 (01)00884838055506(21)13823 (01)00884838055506(21)13824 (01)00884838055506(21)597 (01)00884838055506(21)671 (01)00884838055506(21)1089 (01)00884838055506(21)113 (01)00884838055506(21)1732 (01)00884838055506(21)13156 (01)00884838055506(21)1866 (01)00884838055506(21)2423 (01)00884838055506(21)1427 (01)00884838055506(21)325 (01)00884838055506(21)108 (01)00884838055506(21)3721 (01)00884838055506(21)3189 (01)00884838055506(21)326 (01)00884838055506(21)3093 (01)00884838055506(21)603 (01)00884838055506(21)622 (01)00884838055506(21)924 (01)00884838055506(21)282 (01)00884838055506(21)1984 (01)00884838055506(21)1152 (01)00884838055506(21)3009 (01)00884838055506(21)1059 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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.

device · product 3 of 3

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

Z-0357-2022
Recall number
Z-0357-2022
Initiated
November 12, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Philips North America Llc
Quantity
462 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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 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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.