FDA Device recall Z-1145-2020

VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Az…

FDA Device
Class II
terminated
Published 2020-02-19

On 2020-02-19 the FDA classified a Class II recall of VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Az… by Philips North America, citing due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1145-2020
Classification	Class II
Status	terminated
Initiated	2019-12-23
Published	2020-02-19
Last updated	2026-09-13 11:55 UTC
Company	Philips North America
Distribution	US

Product

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.

Reason

Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.

Identifiers

code_info	Serial Numbers: Azurion: 213 713 711 716 710 709 439 89 320 637 653 684 621 1040 900 866 212 737… 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

code_info

Serial Numbers: Azurion: 213 713 711 716 710 709 439 89 320 637 653 684 621 1040 900 866 212 737…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.