Allura Exper FD Series
Medical device recall Z-1486-2020. Published in FDA’s Enforcement Report on Mar 25, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 25, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 4938 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
4938, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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 5 307 1674 S4F220301A001 531 1 72246F 299 823 442 1037 1977 566 72 448 148 1606 924 1730 1936 2310 1610 686 1109 319 1108 1728 460 1294 568 500 435 679 82 1499 459 469 119 254 894 42 49 293 467 302 2536 1422 1077 987 986 297 1537 1112 2461 285 29A 58U 453 46 243 1596 306 116 175 1953 821 13 289 968 1944 1426 1347 112 791 1317 161 1649 1895 1900 1723 878 1084 2221 638 342 69 505 286 2140 591 2496 2311 2222 1515 1803 2484 378 35 1731 1017 1020 636 170 2823014 CV.381 142 1700 946 215 380 1811 214 2523 2573 2267 527 214 402 2171 1690 267 1878 1497 782 427 2068 1602 1694 1839 209 418 1053 2498 1045 932 755 1585 1558 1365 113 344182 1806 2445 25 2126 1148 1181 241 920 2065 113 339 1716 8477 684 1941 1265 1512 331 213 215 389 732 751 809 1324 2276 2086 763 1285 2219 992 1734 149 2390 35 1031 1837…
FDA’s list runs to 21,471 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide domestic distribution. Foreign distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 30, 2019.
- FDA classified it on Mar 13, 2020.
- FDA’s Enforcement Report published it on Mar 25, 2020.
- FDA terminated it on Nov 17, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Philips North America, LLC, of Andover, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 21,471 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.