Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component…
Medical device recall Z-1144-2024. Published in FDA’s Enforcement Report on Feb 28, 2024.
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 Feb 28, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,993 US; 2,662 OUS 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?
Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may result in delay of procedure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;
1,993 US; 2,662 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Allura Xper FD10 722003 - no UDI Serial Numbers 1181 1187 1311 1349 1435 1594 1700 1788 268 285 368 390 445 467 472 485 913 940 , 722010 - UDI-DI 00884838059030 Serial Numbers 1005 1009 1011 1025 1028 1040 1041 1043 1048 1069 107 1078 1082…
Every code shown here, 1,996 characters
Allura Xper FD10 722003 - no UDI Serial Numbers 1181 1187 1311 1349 1435 1594 1700 1788 268 285 368 390 445 467 472 485 913 940 , 722010 - UDI-DI 00884838059030 Serial Numbers 1005 1009 1011 1025 1028 1040 1041 1043 1048 1069 107 1078 1082 1084 1108 1109 1118 1123 1126 1128 1132 1149 1170 1173 1176 1181 1183 1209 1210 1230 1233 1234 1235 1236 1244 1261 1263 1275 1279 1283 1287 1292 1297 1298 1302 1309 1310 1328 133 1336 1344 1347 1365 1369 1370 1373 1395 1396 1397 1398 1424 1425 1432 1441 1442 175 190 215 244 252 280 33 343 344 365 40 414 42 43 468 488 500 527 585 646 667 668 679 68 690 714 728 754 755 763 767 780 785 787 788 791 818 821 826 830 838 839 873 882 896 902 905 917 920 921 931 932 939 965 968 970 976 986 987 992 999 , 722026 - UDI-DI 00884838054189 Serial Numbers 100 1000 101 102 1050 1051 1052 1068 1072 109 110 112 1126 1132 114 115 116 117 1182 1189 1192 1205 121 1215 122 1239 1248 1268 130 142 151 155 156 185 191 192 204 215 220 222 223 224 233 234 244 245 253 258 259 265 323 324 335 368 378 381 391 394 396 400 431 432 436 458 462 484 485 531 544 558 559 560 561 562 600 601 602 604 608 612 617 622 627 633 634 646 648 653 654 663 664 683 694 704 713 716 725 73 731 738 74 75 765 770 774 778 78 781 786 79 796 805 825 826 832 838 841 843 845 87 877 908 909 93 931 935 942 957 959 965 966 967 969 973 98 985 99 990 ; Allura Xper FD10/10 722005 - no UDI Serial Number 259 261 270 329 343 449 456 480 49 523 63 , 722011 - no UDI Serial Number 123 140 15 172 173 177 23 234 237 255 256 267 268 269 270 275 308 319 324 325 332 344 345 358 362 375 380 49 76 79 82 83 , 722027 - UDI-DI 00884838054196 Serial Number 1 104 106 107 112 116 120 123 127 134 153 156 164 174 175 179 183 202 203 216 222 230 231 234 240 241 255 263 265 266 280 284 288 29 298 305 306 307 32 332 335 342 351 39 41 42 43 49 50 56 71 ; Allura Xper FD20 722006 - UDI-DI 00884838059115 Serial Numbers 1000 1093 1114 1127 1132 1174 1221 1276 1318 1364 1383 1407 1420 1439 1444 1446 1476 1507 1588 1589…
FDA’s list runs to 8,128 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.
Worldwide - US Nationwide distribution.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Jan 2, 2024.
- FDA classified it on Feb 16, 2024.
- FDA’s Enforcement Report published it on Feb 28, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., of Best, Netherlands.
- 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 8,128 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.