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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Navigation

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  Class 2 Device Recall Medtronic Navigation see related information
Date Initiated by Firm May 01, 2019
Create Date July 03, 2019
Recall Status1 Terminated 3 on January 19, 2021
Recall Number Z-1932-2019
Recall Event ID 82991
510(K)Number K092564  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage):
Product Name Model#/ CFN
OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027
OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R
BASE OARM 8170000027100 SYSTEM !DOV BI70000027100
BASE OARM Bl70000027100R SYSTEM lOOV RWK Bl70000027100R
BASE OARM 8170000027120 SYSTEM 120V 8170000027120
BASE OARM Bl70000027120R SYSTEM 120V RWK BI70000027120R
BASE OARM Bl70000027230 SYSTEM 230V 8170000027230
BASE OARM Bl70000027230R SYSTEM 230V RWK BI70000027230R
OARM ASSY BI70000027GER SYS PRODUCT GER BI70000027GER
OARM ASSY Bl70000027GERR SYS PRODUCT REFURB BI70000027GERR
BASE OARM 8170000028100 SYS lOOV 8170000028100
BASE OARM BI70000028120 SYS 120V 8170000028120
BASE OARM BI70000028120R 3RD EDIT REFURB BI70000028120R
BASE OARM BI70000028230 SYS 230V BI70000028230
BASE OARM BI70000028230R 3RD EDIT REFURB Bl70000028230R

Product Usage:
The 0-arrn Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomi~ structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-arm Imaging System is compatible with certain Image Guided Surgery Systems.
Code Information Serial Numbers: US: 00102 00103R 00105 00112R 00113 00116R 00117R 00118R 00126 00128R 00129 00131 00133 00134 00135 00138 00140 00147 00148 00149 00152 00157 00158 00164R 00167 00168 00170 00171 00173 00176 00178 00179 00182 00184R 00185 00186 00188 00189 00190 00191 00199 00202 00205 00210R 00211 00212 00214 00215 00218 00219 00221 00222 00224 00225 00226 00229 00232R 00234R 00235 00236 00238R 00239 00242 00248 00256 00257 00261 00262 00267 00269 00270 00273 00274R 00275 00277 00280 00282 00288 00289R 00293 00294 00296 00297 00300 00305 00306R 00307 00308 00309R 00311 00312R 00313 00314 00315 00317 O-Arm 318 00319R 00333 00335 00341 00342 00343 00344 00347 00348 00350 00351 00359 00360 00362 00363 00365 00366 00369 00370 00373 00377 00378 00379 00381 00383 00385 00391 00392 00394 00396 00398 00399 00400 00401 00404 00405 00406 00408 00409 00410 00412 00415 00416 00418R O-Arm 420 00428 00429 00432 00433 00435 00438R 00439 00441 00442 00443 00444 00445 00446R 00447 00449 00450 00452 00453 O-arm 457 00458 00461 00462 00465 00466R 00469 00470 00471 00474 00475 00476 00479 00480 00484 00485 00487 00489 00490 00494 00496 00497 00499 00500 00502 00503 00507 O-arm 510 00511 00512 00513 00523 00524 00525 00526 00530 00531 00532 00534 00535 00538 00539R 00540 00541 00542 00543 00544 00546 00547 00550 00551 00553 00554 00555 00556 00561 00562 00564 00566 00567 00568 00569 00570 00572 00573 00574 00576 00579 00581 00582R 00583 00584 00586 00587 00588 00592 00595 00597 00598 00599 00600 00602 00603 00604 00608 00611 00614 00618 00622 00623 00627 00628 00634 00639 00640 00645 00655 00659 00664 00665 00667 00668 00669 00670 00671 00672 00673 00674 00675 00676 00677 00678A 00679 00680 00686 00688 00689 00690 00691 00694 00696 00699 00700 00704 00705 00707 00708 00709 00712 00713 00714 B13080721 B13080722 00726 00727 B13090729 00730 00731 00732 00734 00735 00736 00737 00738 00742 00744 00749 00750 00751 00752 00753 00755 00756 00757 B13120763 B13120764 B13120766 B13120768 B14010769 B14010774 B14010775R B14010777 B14010780 B14030785 B14020786 B14020788 B14020792 B14020795 B14030796 B14030797 B14030803 O-arm 804 B14030808 B14040810 B14040814 B14040816 B14040817 B14040819 B14050826 B14050827 O-Arm 831 B14070835 B14060836 O-arm 842 B14070846 B14070847 B14070849 B14070851 B14070852 B14070854 00856 B14070857 00858 B14080859 B14080861 B14080862 B14090863 B14080864 B14080865 B14080866 B14080867 B14080871 B14090872 B14090873 B14090874 B14090880 B14090881 B14090882 B14090883 B14090884 B14090885 B14100886 B14100887 B14100888 B14100889 B14100890 B14100891 B14100893 B14100894 B14100895 B14110896 B14110898 B14110899 B14110901 B14110902 B14110903 B14110904 B14120905 B14120906 B14120907 B14120908 B14120909 B14120910 B14120911 B14120912 B14120913 B14120915 B14120916 B14120917 B14120918 B15010919 B15010920 B15010921 B15010922 B15010923 B15010924 B15010926 B15020925 B15020927 B15020928 B15020937 B15020940 B15020941 B15020942 B15030945 B15030946 B15030947 B15030948 B15030951 B15030952 B15030953 B15030955 B15040958 B15040959 B15040960 B15040961 B15050971 B15050972 B15050975 B15060976 00977 B15060980 B15060984 B15060987 B15060988 B15070992 B15070999 B15071000 B15071003 B15071004 B15081005 B15081008 B15091012 B15091014R B15091017 B15091018 B15091019 B15091020 B15091023 B15091024 B15091026 B15091028 B15091030 B15091032 B15101039 B15121049 B15121058 B15121064 B15121072 B16011082 B16011095 B16031115 B16031120 B16041136 B16041138 B16051159 B16081226 B16101239  Serial Numbers: OUS 00110R 00119 00121 00122 00125 00139 00143 00144 00145 00146 00151 00154 00160 00163 00172 00174 00180R 00196 00197 00201 00206 00207 00208R 00213 00216 00217 00220 00223 00228 00230 00231 00233 00237 00241R 00243 00246R 00247 00250 00251 00252 00253 00263 00264 00265 00266 00276 00278 00279 00283 00284 00285 00286 00287 00290 00291 00292 00295 00301 00303 00320 00321 00322 00323 00324 00325 00326R 00328 00329 00330 00331R 00332R 00334 00336 00337 00338 00339 00345 00349 00353 00354 00357 00361 00364 00367 00368 00371 00372 00375 00376 00380 00384 00386 00388 00393 00397 00402 00407 00411 00417 00421 00422 00423 00424 00425 00427 00430 00431 00436 00440 00448 00451 00454 00455 00456R 00460 00463 00464 00467 00468 00472 00478 00481 00482 00483 00486 00491 00492R 00493 00495 00501 00504 00506 00509 00514 00515 00516 00517 00518 00519 00520 00521 00522 00527 00528 00529 00533 00536 00537R 00549 00552 00557 00558R 00559 00563 00565 00571 00575 00577 00580 00585 00589 00590R 00591 00593 00594 00601 00605 00606 00607 00609 00610 00612 613 00615 00616 00619R 00620 00621R 00624 00625 00626 00630 00631 00632 00633 00635 00636 00637 00638 00641 00642 00643 00644 00647 00648 00649 00650 00651 00652 00653 00654 00657 00658 00660 00661 00662 00663 00666R B13050681 B13050682 B13060683 00684 B13050685 00687 00692 00693 00697 B13060698 00701 00702 00703 B13070710 B13080711 B13080715 B13080716 B13080717 B13080718 B13080719 B13080720 B13090723 B13080724 00725 00728R 00739 00740 00741 00743 00745R 00746 00747 00748 00758 00759 00760 00761 00762 B13120765 B13120770 B14010771 B14010772 B14020773 B14010776 B14010778 B14010779 B14010781 B14010782 B14020784 B14030787 B14020789 B14020790 B14020793 B14020794 B14030798 B14030799 B14030800 B14030801 B14030802 B14030805 B14030806 B14030807 B14040811 B14040812 B14040813 B14050815 00818 B14040820 B14050821 B14050822 B14050823 B14050824 B14050828 B14050829 B14060832 B14060833 B14060834 00837 B14060838 B14070840 00841 B14070843 00844 B14070845 00848 00850 00853 00855 B14080860 00868 B14080869 00870 00892R B14110897R B15020929 B15020938 B15030954 00969 00970 00979 00991 00995 00996 B15101034 B15101041 01048 01078 01088 01093 B16011100 B16021102 B16021105 B16021106 B16021111 B16021112 B16031114 01119 B16031126 01130 B16041137 B16041150 B16051155 B16061164 01184 B16061190 B16061196 01202 B16071207 B16071213 B16071215 B16081234 B17031257 B16111259 B16111272 B16111273 B17011287 B17041310 B17101333 B17101445 B17061451 B17061456 B17071466 B17071480 B17081487 B17101496 B17091526 B17121536 B17121544 B17121561 B17121573 B17121576 B17121581 B17121584 B18021586 B18021593 B18021594 B18041601 
Recalling Firm/
Manufacturer		 Medtronic Navigation, Inc.-Littleton
300 Foster St
Littleton MA 01460-2017
For Additional Information Contact SAME
978-698-6000
Manufacturer Reason
for Recall		 The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly, the batteries will not receive a full recharge of the potential capacity and results in the inability of the system to take X-rays, open the gantry, and move the system from one place to another, which may affect the ability to continue use within the operating room until the charger board and/or the batteries are replaced
FDA Determined
Cause 2		 Device Design
Action Medtronic Navigation issued letter May l, 2019 via FedEx Express Overnight delivery identifying the issue, health risk and action to take: provided a visual mitigation card to attach to the Image Acquisition System (IAS) of their affected systems to serve as a visual reminder. " Consignees will be asked to sign and return the consignee response form; acknowledging receipt of this information and confirmation of having attached the visual mitigation card to their affected system. Review and retain Attachment 8 for further guidance . Attachment B provides instructions for inspecting the battery and chargers. and follow the "Performance Checks and Maintenance" section of your user manual, in addition to the information in Attachment B, to ensure your system is available for surgical procedures Medtronic field service personnel will install a new version of the user manual " Medtronic field service personnel will install a component (Mobile View Station \'MVS'') heatsink) as part of the new design of the AC power input circuit. Questions contact Medtronic Technical Support if you have any questions or concerns regarding this matter: USA: (800) 595-9709 or 720-890-3160 Worldwide: +1-720-890-3160 RS.NA VTECHSUPPORT@M EDTRON IC.COM
Quantity in Commerce 832 units
Distribution Worldwide Distribution - US Nationwide Foreign: ALGERIA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL BULGARIA CANADA CANADA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK EGYPT FINLAND FRANCE GERMANY GREECE HONG KONG INDIA IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KOREA KOREA, REPUBLIC OF KUWAIT LEBANON LIBYAN ARAB JAMAHIRIYA LK MEXICO NETHERLANDS NEW ZEALAND NICARAGUA POLAND PORTUGAL PUERTO RICO RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVAKIA SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED ARAB EMIRATES UNITED KINGDOM VENEZUELA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = MEDTRONIC NAVIGATION, INC. (LITTLETON)
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