Reported Feb 28, 2024 · Ongoing
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of…
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs
14 of 14 products
| # | Product as published |
|---|---|
| 1 | Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026 |
| 2 | Allura Xper FD10 OR Table 722022 |
| 3 | Allura Xper FD10/10 722005 722011 722027 |
| 4 | Allura Xper FD10C 722001 |
| 5 | Allura Xper FD20 722006 722012 722028 |
| 6 | Allura Xper FD20 Biplane 722008 722013 |
| 7 | Allura Xper FD20 Biplane OR Table 722025 |
| 8 | Allura Xper FD20 OR Table 722023 722035 |
| 9 | Allura Xper FD20/10 722029 |
| 10 | Allura Xper FD20/15 722058 |
| 11 | Allura Xper FD20/15 OR Table 722059 |
| 12 | Allura Xper FD20/20 722038 |
| 13 | Allura Xper FD20/20 OR Table 722039 |
| 14 | (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.) |
- Lot codes and dates
- Allura Xper FD10 722003 - no UDI Serial Numbers, 722010 - UDI-DI 00884838059030 or 00884838059191, some units do not have UDI Serial Numbers
1031105107411141181118712091311134914351472152915551594170017191788268283285368390445467472482485690906912913928940
33 337 343 344 359 360 365 38 39 40 414 42 422 423 4399 of 99 codes
1005100910111025102810401041104210431048106410691071078108210841108110911121118112311261128113211441149117011731176118111831209121012141226123012331234123512361244126112631275127912831287129212971298130213081309131013121328133133613441347
61453467468477478479480485488500505521527531567572585592604605609
65611624636637638641646648
68651656662667668670671673675677679
, 722026 - UDI-DI 00884838054189 Serial Numbers683690693694698714728730754755763764767780784785787788791792794809818821826830833838839873878882890896902905914917920921931932937939946965968970976979986987992999
111001000101102103810501051105210681072109
73 731 738 74 75 765 770 774 778 78 781 782 786 79122 of 122 codes
11011001101112112611291132114115116117118211891192120512112101215122123112391246124812681287129313013381340142151155156185190191192201204205215220221222223224233234235244245253258259265284287297319323
87 877 878 882 908 909 914 93796805825826832838841843845855
98 985 99 990 ; Allura Xper FD10 OR Table 722022 - No UDI Serial Number 6 ; Allura Xper FD10/10 722005 - UDI-DI 00884838080805 Serial Numbers931935942957959965966967969973
49 523 63 , 722011 - no UDI Serial Numbers212259261270329343344392399449456474480
15101102103107123124132133137140
23155157163168169170171172173177196205
33 332 344 345 358 362 375 380 44 49 57 58 59 72 76 79 82 83 84 87 95 , 722027 - UDI-DI 00884838054196 or 00884838059191 Serial Numbers 1234237255256267268269270275279308319324325
29 298 305 306 307 319 32 332 335 342 351 39 40 41 42 43 49 50 56 71 ; Allura Xper FD10C 722001 - no UDI Serial Numbers 213 273 ; Allura Xper FD20 722006 - UDI-DI 00884838059115 Serial Numbers104106107112116120123127133134152153156164169174175178179183202203209216222230231234240241246255263265266267280284288
39 4582 of 82 codes
10001007109311041114112711321174120121012211235125912761318134113641383138714071420143914441446146114691476148015071588158916041610162716481659166117051720172917521761177217921807181218271830184518461848187018721875188819131921192219421955
, 722012 - UDI-DI 00884838059054, 00884838059191, or 00884838059207 Serial Numbers468518559560587638641673674675680683700722723767774776804806810878882886904972
66 666 669 67 671 675 676 68 685 686 689 69 690 691 694 695 70568 of 568 codes
10010011002100310041005101101410161017101910201022102310261027103103210331034103510361037103810410441045104710531054105810621063107310751077107810831084109110921095109610971098109911001101110211041105110611081113111511161117111811191120
76718731732733735740741751756757758
84760766767768782787788789790791792796797814815823828
86 861 865 878 88 888 892 893 894 909 919 92 920 923 924 925 926 93 934 935 939 943 948 95846848851852855856858859
99 990 D902-214-00 , 722028 - UDI-DI 00884838054202, 00884838059191, 00884838059269 Serial Numbers 1950951952953954959963964971973974975976986989
111000100110021004101110141017102210241030103210341035104110431049105010511054105810681069107410761077108110851094109510981099
31305 of 305 codes
1101100110311111116112211291130113211361142114911541155115611681171118711881189119112001201120212112111212121312141221222123212331244125125612611264126612671269127127512791281286128812913013113101311132132613271331331133313401343
4865 of 65 codes
310313315316317318324326329333336339340343346347350356361363364365368371372373375376377379382386394402406407408416419420422424426428431435437445447449451452453454456459462463464466
52481485488489490491493494496498499516518519
66 664 666 668 669 67520521522525526528529530531533534535538539540541543547548549550552553556558559560561564565570571579580582586590591592596601618620625627630631632634636637638647654655
71671672674675677678680684691692695696697698
80710717720721729731734741743744751757759768774779781784785793
; Allura Xper FD20 Biplane 722008 - no UDI Serial Numbers 115 124 133 142 173 1789 1977 of 77 codes
805806808809811818819821825840842854861864866867869874877879880882887888889891892893895896900901903904906908909910911914917918922924925928929930932934938940945946949952956961962966
, 722013 - UDI-DI 00884838059061 or 00884838080805 Serial Numbers197231246264267288306312319349378419420445453463465472487491516521
30100105106113115124125126129140141147148149150151152153159160164170174175178179194203205213214216217218228241244246249253254255262264266267268269274278289290293297
35303304307308309313316327328330342346347
42 422 424 426 427 428 43 435 441 442 45 46351357360375377379383389392401402404410
61 626 631 634 637 638 639 69 72 74 77 84 85 96 ; Allura Xper FD20 Biplane OR Table 722025 - no UDI Serial Numbers 2 3 ; Allura Xper FD20 OR Table 722023 - UDI-DI 00884838059085 Serial Numbers 109 110 113 116 117 118 12461462467475479480481491492495496497500505507511513515518519531550556561562564573575580599601603
18 26 27 35 41 42 46 49 64 66 71 72 75 82 83 98 , 722035 - UDI-DI 00884838054240 Serial Numbers124127128138142147160175179
21 212 216 222 236 24 242 243 244 245 246 247 252 30 34 38 46 47 52 57 59 60 72 74 85 88 89 ; Allura Xper FD20/10 722029 - UDI-DI 00884838054219 Serial Numbers 100 110 126 129 21 22 30 31 36 55 56 57 60 62 63 7 71 84 88 91 94 95 97 ; Allura Xper FD20/15 722058 - UDI-DI 00884838059115 or 00884838059191 Serial Numbers100101117119121123124125126127131143145147161165169172183187192196
22 23 238 239 24100109111123124129134135138146149156162167168171172178182186190196197199200202203205212215219
38 4 405 5 56 59 61 65 71 82 85 94 99 ; Allura Xper FD20/15 OR Table 722059 - UDI-DI 00884838059122 Serial Numbers 33 7 ; Allura Xper FD20/20 722038 - UDI-DI 00884838054226 Serial Numbers249254257259264265274277278279285288290304305319325337340365366373378
35 37 38 39 41 42 46 48 49 55 60 62 63 67 7 70 71 78 96 99 ; Allura Xper FD20/20 OR Table 722039 - No UDI Serial Number 3 ;106108115118119120126130131137141157167173
- Allura Xper FD10 722003 - no UDI Serial Numbers
- Amount recalled
- 13, 133 (3,408 US; 9,725 ROW)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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