VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips…
Medical device recall Z-1145-2020. Published in FDA’s Enforcement Report on Feb 19, 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 Feb 19, 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
- 443 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?
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.
443, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: Azurion: 213 713 711 716 710 709 439 89 320 637 653 684 621 1040 900 866 212 737 628 895 281 1023 697 793 146 422 912 42 50 738 1103 1006 296 403 267 879 428 587 251 706 611 420 877 925 56 897 896 940 574 70 141 865 1049 71…
Every code shown here, 1,791 characters
Serial Numbers: Azurion: 213 713 711 716 710 709 439 89 320 637 653 684 621 1040 900 866 212 737 628 895 281 1023 697 793 146 422 912 42 50 738 1103 1006 296 403 267 879 428 587 251 706 611 420 877 925 56 897 896 940 574 70 141 865 1049 71 939 584 1084 945 838 875 853 856 354 931 909 114 47 196 62 70 222 474 401 370 703 41 608 247 1098 797 335 483 837 360 255 471 1043 323 228 359 277 974 564 416 35 43 40 274 225 466 750 814 1016 328 329 265 679 128 644 275 783 489 37 293 74 341 346 66 77 759 302 557 550 756 194 1129 356 234 75 7 316 215 24 971 38 37 36 1133 76 524 406 949 1004 735 421 68 773 958 642 643 408 407 581 907 643 826 354 545 902 917 963 105 894 1083 414 1036 559 560 236 237 745 744 217 418 152 1035 313 1037 215 61 561 815 765 112 224 1052 282 444 339 138 529 405 381 162 79 35 638 410 134 583 824 254 52 190 285 242 127 219 876 76 290 47 787 812 784 221 336 874 299 228 1044 315 521 323 367 260 395 126 662 258 547 509 240 63 386 582 533 518 238 515 985 463 983 297 288 929 768 256 186 487 105 636 274 278 112 49 202 893 651 500 794 296 225 528 100 139 311 635 260 200 201 541 61 122 128 129 457 504 548 798 647 1072 367 435 1015 729 344 343 943 292 600 825 246 458 586 328 1073 648 191 652 334 173 233 289 1194 565 1195 148 1191 566 238 916 301 555 556 1192 1196 1190 553 934 430 399 400 364 720 51 1089 1008 271 491 492 60 370 369 1080 283 1019 1046 1081 781 775 286 398 349 941 780 334 1076 616 657 309 411 83 1065 549 1075 984 450 786 210 192 166 144 293 578 195 142 28 29 659 258 20 29 118 392 544 133 743 1106 722 355 932 686 551 235 1109 287 286 371 39 179 767 300 182 701 482 772 25 936 493 160 819 317 1074 835 484 665 115 522 523 338 1034 778 207 452 1172 969 231 377 380 379 88 461 316 446 346 336 694 34 1056 45 41 42 44 43 141 432 391 764 Allura: 25 28 39 38
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 Distribution. US nationwide, Canada, Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Latvia, Libya, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Uruguay.
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 23, 2019.
- FDA classified it on Feb 10, 2020.
- FDA’s Enforcement Report published it on Feb 19, 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.”
- 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.