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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Azurion 7

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  Class 2 Device Recall Philips Azurion 7 see related information
Date Initiated by Firm January 02, 2024
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1145-2024
Recall Event ID 93783
510(K)Number K200917  K172822  K181830  
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: FlexViewing PC

Azurion Model Name - Model Number:

Azurion 7 B12
722067;
Azurion 7 B20
722068;
Azurion 7 M12
722078
722223;
Azurion 7 M20
722079;
Code Information 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 101 103 104 107 110 111 113 114 117 130 136 137 143 146 147 149 150 153 170 172 178 184 196 205 213 232 243 247 261 262 277 288 295 322 330 356 361 470 64 73 75 76 78 82 84 85 89 95 ; Azurion 7 M12 722078 - UDI-DI 00884838085251 Serial Numbers 121 125 136 141 163 165 166 187 215 224 232 239 240 249 251 256 257 258 269 271 278 279 289 290 291 292 293 294 296 298 302 305 308 309 31 317 327 359 360 364 376 379 383 384 396 399 402 412 415 425 436 437 438 441 445 456 478 479 480 481 483 491 493 497 500 523 524 535 537 538 539 550 571 , 722223 - UDI-DI 00884838099241 Serial Number 206 ; Azurion 7 M20 722079 - UDI-DI 00884838059191, 00884838059221, 00884838059290, 00884838085268, 00884838086777 Serial Numbers 1018 1042 1063 1211 1267 1274 1380 1382 18 19 212 213 216 222 227 228 229 239 241 247 250 251 255 262 263 266 267 268 273 274 275 281 29 290 296 297 298 299 30 314 318 32 320 325 326 327 33 334 335 34 343 344 345 35 350 351 353 354 355 356 357 358 359 360 361 366 374 375 387 393 394 40 401 402 403 407 408 41 412 413 414 415 417 420 422 423 424 427 428 429 43 436 437 438 439 445 447 448 45 453 455 459 46 460 465 466 468 469 47 470 471 472 474 479 48 483 488 497 50 51 52 520 525 526 528 53 534 535 536 54 540 543 55 56 564 57 572 573 574 577 58 580 581 584 585 588 590 593 594 595 598 599 60 602 605 607 608 611 613 617 618 62 621 628 629 631 633 634 637 64 645 646 65 653 654 655 658 663 668 669 673 674 68 684 689 691 697 70 702 703314 703333 703402 706 709 710 711 713 715 716 717 730 736 737 738 741 742 751 753 754 755 758 766 776 777 78 790 792 795 804 809 810 813 817 820 836 838 841 842 843 848 854 862 863 865 866 877 878 888 891 895 910 915 921 923 931 939 942 ;
Recalling Firm/
Manufacturer		 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 4-6
Best Netherlands
Manufacturer Reason
for Recall		 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.
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 Framegrabber Card 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 1,993 US; 2,662 ROW
Distribution Worldwide - US Nationwide distribution.
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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