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
4 of 4 products
| # | Product as published |
|---|---|
| 1 | FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067 |
| 2 | Azurion 7 B20 722068 |
| 3 | Azurion 7 M12 722078 722223 |
| 4 | Azurion 7 M20 722079 |
- Lot codes and dates
- Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 104 131 133 141 148 26 36 41 42 46 57 69 70 71 75 81 92 98 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, or 00884838085367 Serial Numbers64 73 75 76 78 82 84 85 89 95 ; Azurion 7 M12 722078 - UDI-DI 00884838085251 Serial Numbers
101103104107110111113114117130136137143146147149150153170172178184196205213232243247261262277288295322330356361470
31121125136141163165166187215224232239240249251256257258269271278279289290291292293294296298302305308309
, 722223 - UDI-DI 00884838099241 Serial Number 206 ; Azurion 7 M20 722079 - UDI-DI 00884838059191, 00884838059221, 00884838059290, 00884838085268, 00884838086777 Serial Numbers317327359360364376379383384396399402412415425436437438441445456478479480481483491493497500523524535537538539550571
18 1910181042106312111267127413801382
29 290 296 297 298 299 30 314 318 32 320 325 326 327 33 334 335 34 343 344 345 35212213216222227228229239241247250251255262263266267268273274275281
40 401 402 403 407 408 41350351353354355356357358359360361366374375387393394
43 436 437 438 439 445 447 448 45 453 455 459 46 460 465 466 468 469 47 470 471 472 474 479 48 483 488 497 50 51 52 520 525 526 528 53 534 535 536 54 540 543 55 56 564 57 572 573 574 577 58412413414415417420422423424427428429
60580581584585588590593594595598599
62 621 628 629 631 633 634 637 64 645 646 65602605607608611613617618
68 684 689 691 697 70653654655658663668669673674
78702703314703333703402706709710711713715716717730736737738741742751753754755758766776777
;790792795804809810813817820836838841842843848854862863865866877878888891895910915921923931939942
- Azurion 7 B12 722067 - UDI-DI 00884838059290, 00884838064775, or 00884838085350 Serial Numbers 104 131 133 141 148 26 36 41 42 46 57 69 70 71 75 81 92 98 ; Azurion 7 B20 722068 - UDI-DI 00884838059207, 00884838064775, or 00884838085367 Serial Numbers
- Amount recalled
- 1,993 US; 2,662 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
- Nationwide
Why it was recalled
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.
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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