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U.S. Department of Health and Human Services

Class 2 Device Recall VesselNavigator application

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 Class 2 Device Recall VesselNavigator applicationsee related information
Date Initiated by FirmDecember 23, 2019
Date PostedFebruary 10, 2020
Recall Status1 Terminated 3 on November 17, 2022
Recall NumberZ-1145-2020
Recall Event ID 84708
510(K)NumberK162148 K172822 K181830 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductVesselNavigator 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.
Code Information 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 
Recalling Firm/
Manufacturer		 Philips North America, LLC
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information ContactTechnical Services
800-722-9377
Manufacturer Reason
for Recall		Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
FDA Determined
Cause 2		Software design
ActionOn 12/23/2019, the firm sent medical device correction letters to affected customers via certified mail. The firm will be contacting customers with affected systems. The firm will be implementing software updates in all affected systems to correct the issue which was made available by the end of December 2019. The user was asked to do the following: -Please suspend the use of Digital Subtraction Angiography images for the verification of the registration during the Live Guidance step. -Please ensure that all staff working with the VesselNavigator application are informed of the recall. If you need further information or support concerning this issue, please contact your local Philips representative or call Technical Support Line at 1-800-722-9377.
Quantity in Commerce443
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OWB
510(K)s with Product Code = OWB
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