Reported Feb 28, 2024 · Ongoing
Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the…
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 Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs
7 of 7 products
| # | Product as published |
|---|---|
| 1 | XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221 |
| 2 | Azurion 3 M15 722064 722222 |
| 3 | Azurion 5 M20 722228 |
| 4 | Azurion 7 B12 722067 722225 |
| 5 | Azurion 7 B20 722068 722226 |
| 6 | Azurion 7 M12 722078 722223 |
| 7 | Azurion 7 M20 722079 722224 |
- Lot codes and dates
- Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9 ; Azurion 3 M15 722064 - UDI-DI 00884838085282 Serial Numbers64 , 722222 - UDI-DI 00884838099210 Serial Numbers 12 15 17 19 23 ; Azurion 5 M20 722228 - UDI-DI 00884838099234 Serial Numbers 10 17 18 23 24 25 26 29 38 49 62 ; Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers
201209218229238258259260261267270291314335
26 277 278 36 41 42 46 57 69 70 71 75 81 92 98 , 722225 - UDI-DI 00884838099265 Serial Numbers 28 29 37 41 53 72 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, 00884838085367, or 00884838101883 Serial Numbers103104109114115123131132133141147148150163172173190192208214221225234244250
4265 of 65 codes
101103104107109110111113114117130136137143146147149150153170172178184196205213225232239243247251261262270271277279282285288295304308319320322323324329330335337350354356361370373374
64 73 75 76 78 82 84 85 89 95 , 722226 - UDI-DI 00884838099272 or 00884838101883 Serial Numbers 100 105 107 108 11431440442443446457462467469470472477479487490494505510511520524528547564
19 220 255 59 67 75 78 98 ; Azurion 7 M12 722078 - UDI-DI 00884838085251 or 00884838101890 Serial Numbers112113117120121122123124125126127129139143144147153159173174180181
221007121125136141143163165166170187215
31224232239240249251256257258269271278279289290291292293294296298302305308309
, 722223 - UDI-DI 00884838099241 or 00884838101890 Serial Numbers101 of 101 codes
317327359360364376379383384396399402410412415425436437438441445456465478479480481483488491493497500513520521522523524532535536537538539544545546550556557558559566571576585598603611
29 36 37 44 47 52 67 69 77 85 87 96 97 ; Azurion 7 M20 722079 - UDI-DI 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838101883, or 00884838101890 Serial Numbers104105124126127130131161171177180186187188189196198
18 19130 of 130 codes
100510061007101010121013101810211022102310321033104010411042104310481049105410591062106310641078108410861090109610971098110011021103110711081117113711421155115611571163116411701171117911871189120012011204121112121213121612191222122612301231
29 290 296 297 298 299 30 314 318 32 320 325 326 327 33 334 335 34 342 343 344 345 35212213216222227228229239241246247250251255262263266267268272273274275281
40 401 402 403 407 408 41350351353354355356357358359360361366374375387393394396
43 436 437 438 439 445 447 448 45 453 455 459 46 460 465 466 468 469 47 470 471 472 474 479 48 480 481 483 488 496 497 499 50 51 52 520 525 526 528 53 534 535 536 537 54 540 543 55 56 564 57 572 573 574 577 58412413414415416417420422423424427428429
60580581584585587588590593594595598599
62 621 628 629 631 633 634 637 64 645 646 65602605607608611613617618
68 684 689 691 697 70653654655658663668669671673674
78102 of 102 codes
702703703305703306703307703308703309703310703311703314703317703323703324703327703329703332703333703334703335703336703344703345703350703360703368703379703383703387703389703390703391703395703396703402703404703407703408703409703413703416703418703419703420703425703426703435703450703455703456703457703465703478703486703493703495703497703501703508703510703515
, 722224 - UDI-DI 00884838059184, 00884838059191, 00884838059207, 00884838099258, or 00884838101883 Serial Numbers95 of 95 codes
790792793795797800801802804805809810813817818820828836837838840841842843847848854856857858859860862863865866867868877878879881883884885887888890891895896897898899900903904905908909
2898 of 98 codes
10010031011021031041051061071081091101121131151161191201235124124012512781281291301311341391401411471481511531541591601631641651661741761771781821831830185187188189190191192194210215216
33 331 332 333 335 339 34 342 343 346 350 36285286287288289291295298301306307308312326327329
39 391 395 40 400 404 409 41 414 42 425 43 433 435 436 441 45 452 453 46 461 466 47 472 482 49 490 50 503 512 526 53 554 56 564 587 592 622 64 715 72 735 75 76 763 78 79 80 82 84 88 90 91 94 99 ;360362363364366369370373374381385
- Azurion 3 M12 722063 - UDI-DI 00884838085275 or 00884838086777 Serial Numbers 108 122 131 132 56 64 84 96 98 , 722221 - UDI-DI 00884838099203 Serial Numbers 19 3 6 7 9 ; Azurion 3 M15 722064 - UDI-DI 00884838085282 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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