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.
Publicado el 10 de julio de 2019 · Inicio del retiro: 1 de mayo de 2019
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Navigation, Inc.-Littleton
- Distribuidor
- 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
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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