Recall Z-1486-2020
Philips North America, LLC · initiated December 30, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
Codes / lots: Serial Codes 491 1117 327 316 535 2522 505 1681 133 2268 1001 972 2577 S01H006016/000001 CV149 1651 231 601 1014 2324 1673 CV.563 1712 1043 1806 2229 247 585 217 313 2158 1946 476 1545 517 107 70 492 1891 1715 157 265 935 145 83 71 1356 50 1250 1659 34 2462 1613 2006 480 2562 1550 1440 1734 1733 2201 1922 741 499 2283 1268 1359 833 116 1599 153 787 410 1848 1445 2122 865 360 268 1238 135 1655 2131 489 12 290 1908 74 365 1166 1336 2404 635249 1792 1960 169 196 1113 83 2569 284 39 1195 1461 203 494 839 2138 2141 1953 1956 1106 1096 754 308 580 335 1048 1804 175 343 1011 1497 1473 234 1408 914 255 215 105 662 2382 301 2281 637 917 18204 18158 1764 276 1401 1588 155 38 583 595 594 576 108 159 671 677 590 2302 1279 168 2198 452 2151 321 1436 468 1132 161 670 1025 700 142 1188 27 1034 545 2454 861 1209 1467 789 1226 2134 481 893 1214 290 1187 1455 2085 358 2505 2202 411 2301 1108 401 1541 423 319 1927 1928 2570 1705 2571 2524 926 796 274 2307 67 2200 1798 404 1656 98 399 990 126 371 528 1636 1871 1302 2506 1309 206 1119 47U 141 154 195 2586 1761 951 57 160 27 1652 692 1435 34 1590 1597 147 259 1073 92 509 244 106 59 516 328 346 1797 638 2441 2267 23 281 596 1054 1189 527 1442 461 1099…
Reason for recall
A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
FDA-determined cause: Component design/selection
Action taken
On December 30, 2019, the firm notified customers via Medical Device Correction letter. Customers were informed of the product issue and advised to do the following: If the capacitor of the Velara X-Ray fails as described (capacitor failure after large number of surges in a short period of time), please switch off the system, take it out of service immediately, and contact your local Philips representative. The firm will be resolving the issue by replacing a Printed Circuit Board (PCB) in the convertor, which prevents the capacitor from failing. PCB replacements started in January 2020. Customers will be contacted by their local Philips representatives to schedule a date for the PCB replacement. Customers with further questions should contact the Technical Support Line: 1-800-722-9377.
Details
- Recall number
- Z-1486-2020
- Initiated
- December 30, 2019
- Terminated
- November 17, 2022
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 4938
- Distribution
- Nationwide domestic distribution. Foreign distribution worldwide.
- Recalling firm
- Philips North America, LLC, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1487-2020 Class II | Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1488-2020 Class II | Integris Allura 9, system codes 722018 722021A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1489-2020 Class II | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1490-2020 Class II | OmniDiagnost Eleva System codes 708028 708027A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1491-2020 Class II | Poly G Integris H5000, System code 72246A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1492-2020 Class II | UroDiagnost Eleva, system code 708033A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1493-2020 Class II | Allura CV20, system code 722031A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |
| Z-1494-2020 Class II | Cardio Vascular-Allura Centron, system code 722400A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | 12/30/2019Terminated |