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U.S. Department of Health and Human Services

Class 2 Device Recall Azurion R2.1

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  Class 2 Device Recall Azurion R2.1 see related information
Date Initiated by Firm January 02, 2024
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1152-2024
Recall Event ID 93781
510(K)Number K200917  K172822  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system.

Affected PCs: XRay PC, Suite PC, and FlexViewing PC

Azurion Model Name - Model Number:

Azurion 3 M12
722063
722221;
Azurion 3 M15
722064
722222;
Azurion 5 M20
722228;
Azurion 7 B12
722067
722225;
Azurion 7 B20
722068
722226;
Azurion 7 M12
722078
722223;
Azurion 7 M20
722079
722224;
Code Information 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 201 209 218 229 238 258 259 260 261 267 270 291 314 335 64 , 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 103 104 109 114 115 123 131 132 133 141 147 148 150 163 172 173 190 192 208 214 221 225 234 244 250 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 Numbers 101 103 104 107 109 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 225 232 239 243 247 251 261 262 270 271 277 279 282 285 288 295 304 308 319 320 322 323 324 329 330 335 337 350 354 356 361 370 373 374 400 406 407 413 418 42 431 440 442 443 446 457 462 467 469 470 472 477 479 487 490 494 505 510 511 520 524 528 547 564 64 73 75 76 78 82 84 85 89 95 , 722226 - UDI-DI 00884838099272 or 00884838101883 Serial Numbers 100 105 107 108 11 112 113 117 120 121 122 123 124 125 126 127 129 139 143 144 147 153 159 173 174 180 181 19 220 255 59 67 75 78 98 ; Azurion 7 M12 722078 - UDI-DI 00884838085251 or 00884838101890 Serial Numbers 1007 121 125 136 141 143 163 165 166 170 187 215 22 224 232 239 240 249 251 256 257 258 269 271 278 279 289 290 291 292 293 294 296 298 302 305 308 309 31 317 327 359 360 364 376 379 383 384 396 399 402 410 412 415 425 436 437 438 441 445 456 465 478 479 480 481 483 488 491 493 497 500 513 520 521 522 523 524 532 535 536 537 538 539 544 545 546 550 556 557 558 559 566 571 576 585 598 603 611 612 613 626 627 635 644 645 649 654 656 657 658 661 677 679 684 697 700 709 719 720 723 725 728 748 753 786 788 803 824 829 833 840 844 862 870 876 890 902 906 921 , 722223 - UDI-DI 00884838099241 or 00884838101890 Serial Numbers 104 105 124 126 127 130 131 161 171 177 180 186 187 188 189 196 198 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 Numbers 1005 1006 1007 1010 1012 1013 1018 1021 1022 1023 1032 1033 1040 1041 1042 1043 1048 1049 1054 1059 1062 1063 1064 1078 1084 1086 1090 1096 1097 1098 1100 1102 1103 1107 1108 1117 1137 1142 1155 1156 1157 1163 1164 1170 1171 1179 1187 1189 1200 1201 1204 1211 1212 1213 1216 1219 1222 1226 1230 1231 1232 1235 1236 1237 1238 1242 1245 1246 1247 1250 1251 1252 1258 1267 1268 1270 1271 1274 1276 1282 1283 1285 1289 1290 1297 1309 1310 1311 1312 1316 1322 1323 1346 1352 1355 1358 1359 1360 1361 1363 1365 1369 1370 1378 1379 1380 1381 1382 1385 1386 1387 1391 1392 1393 1395 1399 1400 1401 1402 1408 1410 1411 1412 1414 1423 1424 1430 1431 1432 1436 18 19 212 213 216 222 227 228 229 239 241 246 247 250 251 255 262 263 266 267 268 272 273 274 275 281 29 290 296 297 298 299 30 314 318 32 320 325 326 327 33 334 335 34 342 343 344 345 35 350 351 353 354 355 356 357 358 359 360 361 366 374 375 387 393 394 396 40 401 402 403 407 408 41 412 413 414 415 416 417 420 422 423 424 427 428 429 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 58 580 581 584 585 587 588 590 593 594 595 598 599 60 602 605 607 608 611 613 617 618 62 621 628 629 631 633 634 637 64 645 646 65 653 654 655 658 663 668 669 671 673 674 68 684 689 691 697 70 702 703 703305 703306 703307 703308 703309 703310 703311 703314 703317 703323 703324 703327 703329 703332 703333 703334 703335 703336 703344 703345 703350 703360 703368 703379 703383 703387 703389 703390 703391 703395 703396 703402 703404 703407 703408 703409 703413 703416 703418 703419 703420 703425 703426 703435 703450 703455 703456 703457 703465 703478 703486 703493 703495 703497 703501 703508 703510 703515 703521 703528 703532 703540 703558 703559 703562 703575 703584 703615 703775 703861 706 708 709 710 711 713 714 715 716 717 721 730 731 736 737 738 741 742 746 747 751 753 754 755 758 766 769 774 776 777 78 790 792 793 795 797 800 801 802 804 805 809 810 813 817 818 820 828 836 837 838 840 841 842 843 847 848 854 856 857 858 859 860 862 863 865 866 867 868 877 878 879 881 883 884 885 887 888 890 891 895 896 897 898 899 900 903 904 905 908 909 910 911 912 915 919 921 922 923 925 927 928 930 931 937 938 939 940 942 944 945 946 948 954 955 957 959 974 981 987 989 990 991 992 998 999 , 722224 - UDI-DI 00884838059184, 00884838059191, 00884838059207, 00884838099258, or 00884838101883 Serial Numbers 100 1003 101 102 103 104 105 106 107 108 109 110 112 113 115 116 119 120 1235 124 1240 125 1278 128 129 130 131 134 139 140 141 147 148 151 153 154 159 160 163 164 165 166 174 176 177 178 182 183 1830 185 187 188 189 190 191 192 194 210 215 216 217 218 219 220 224 225 226 228 229 2308 232 233 234 235 238 239 240 244 246 250 251 252 253 254 260 261 262 265 266 267 268 271 272 273 275 277 278 279 28 285 286 287 288 289 291 295 298 301 306 307 308 312 326 327 329 33 331 332 333 335 339 34 342 343 346 350 36 360 362 363 364 366 369 370 373 374 381 385 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 ;
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure.
FDA Determined
Cause 2		 Process design
Action On January 2, 2024, the firm notified affected consignees via" URGENT Medical Device Correction" letters. These letters covered issues with three components of the PCs that may not perform as intended and which may therefore lead to delay in treatment: 1) DIMMs, 2) Disk Bay, and 3) Framegrabber Card. This recall record is for the Disk Bay issue. Customers should circulate the notice to all users and establish an emergency protocol for if you experience the issue during a procedure. Customers were provided with monitoring activities to undertake while waiting for their system to be corrected. Philips will be replacing the three components in all affected systems. Philips will contact customers to schedule a visit to replace the affected components. If you need additional information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377 (Philips Customer Care Solutions Center).
Quantity in Commerce 13, 133 (3,408 US; 9,725 ROW)
Distribution Worldwide Distribution: US nationwide including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and OUS (International) to countries of: Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, and Yemen.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OWB and Original Applicant = Philips Medical Systems Nederland BV
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