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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 085 01 11 000
Date submitted: 1/31/2011
Manufacturer:Varian Medical Systems
Device Type:Clinac 2100, Linear Accelerator System
Description:Image Digitization Systems
Medical Device Identifier:Serial Numbers: H140025 H140753 H140845 H140896 H272157 H272963 H291040 H291187 H293443 H293691 H140038 H140769 H140846 H140901 H272158 H272981 H291048 H291190 H293447 H293696 H140045 H140772 H140848 H140902 H272165 H272982 H291050 H291206 H293475 H293700 H140047 H140773 H140849 H140904 H272178 H272985 H291051 H291226 H293496 H293709 H140078 H140777 H140850 H140906 H272187 H273049 H291053 H291230 H293507 H293725 H140092 H140780 H140851 H182012 H272188 H273065 H291060 H291234 H293519 H293726 H140096 H140781 H140853 H271167 H272216 H273162 H291067 H291242 H293538 H293727 H140097 H140783 H140854 H271370 H272220 H273170 H291072 H291247 H293541 H293728 H140122 H140787 H140855 H271378 H272231 H273202 H291081 H291248 H293560 H293736 H140124 H140790 H140856 H271385 H272309 H273203 H291084 H291251 H293565 H293737 H140125 H140794 H140857 H271531 H272310 H290278 H291088 H291253 H293577 H293749 H140144 H140795 H140858 H271588 H272325 H290282 H291096 H291254 H293581 H293769 H140146 H140797 H140863 H271607 H272360 H290362 H291099 H291262 H293592 H293773 H140148 H140799 H140864 H271618 H272377 H290399 H291107 H291270 H293596 H293774 H140201 H140800 H140865 H271662 H272401 H290400 H291115 H291271 H293611 H293775 H140202 H140801 H140866 H271663 H272426 H290402 H291116 H291272 H293624 H293778 H140206 H140808 H140867 H271729 H272427 H290501 H291117 H293312 H293627 H293779 H140214 H140812 H140868 H271785 H272440 H290503 H291118 H293325 H293632 H293780 H140216 H140816 H140869 H271825 H272456 H290510 H291119 H293327 H293636 H293781 H140218 H140817 H140871 H271890 H272473 H290512 H291124 H293335 H293638 H293790 H140222 H140818 H140874 H271906 H272491 H290519 H291133 H293342 H293642 H293802 H140223 H140819 H140876 H271926 H272497 H291007 H291136 H293353 H293644 H293804 H140224 H140820 H140877 H271941 H272500 H291008 H291138 H293361 H293646 H293805 H140233 H140824 H140881 H271951 H272826 H291011 H291143 H293363 H293649 H293818 H140240 H140826 H140882 H271954 H272834 H291014 H291149 H293370 H293650 H293820 H140718 H140829 H140883 H271994 H272842 H291017 H291154 H293379 H293652 H293825 H140719 H140830 H140886 H272000 H272873 H291019 H291159 H293401 H293653 H293829 H140721 H140832 H140887 H272014 H272885 H291021 H291169 H293411 H293657 H293830 H140741 H140836 H140889 H272016 H272908 H291022 H291170 H293414 H293662 H293835 H140742 H140840 H140891 H272029 H272910 H291025 H291171 H293431 H293663 H293839 H140747 H140841 H140892 H272064 H272933 H291028 H291172 H293433 H293664 H293841 H140749 H140843 H140893 H272081 H272946 H291035 H291178 H293438 H293686 H293846 H140751 H140844 H140895 H272111 H272960 H291037 H291184 H293439 H293690 H293847 H293848 H294007 H294135 H294244 H294332 H294415 H294500 H294567 H294656 H294732 H293860 H294012 H294140 H294246 H294338 H294418 H294501 H294568 H294657 H294735 H293866 H294013 H294141 H294248 H294340 H294420 H294505 H294569 H294658 H294739 H293872 H294020 H294146 H294252 H294342 H294423 H294508 H294571 H294660 H294742 H293875 H294022 H294149 H294256 H294343 H294425 H294509 H294572 H294661 H294744 H293878 H294023 H294150 H294263 H294345 H294426 H294513 H294573 H294665 H294745 H293880 H294024 H294155 H294264 H294347 H294427 H294514 H294581 H294666 H294747 H293886 H294032 H294157 H294265 H294348 H294429 H294517 H294587 H294667 H294750 H293888 H294033 H294158 H294266 H294350 H294430 H294518 H294589 H294668 H294752 H293889 H294035 H294162 H294267 H294351 H294431 H294520 H294590 H294671 H294753 H293890 H294037 H294163 H294268 H294352 H294433 H294521 H294591 H294674 H294754 H293899 H294043 H294164 H294272 H294355 H294434 H294523 H294593 H294675 H294758 H293902 H294048 H294166 H294278 H294362 H294436 H294524 H294594 H294676 H294761 H293903 H294053 H294167 H294279 H294363 H294437 H294528 H294595 H294678 H294762 H293906 H294055 H294169 H294282 H294364 H294438 H294530 H294598 H294679 H294763 H293908 H294057 H294171 H294284 H294366 H294443 H294531 H294603 H294681 H294766 H293909 H294061 H294176 H294290 H294369 H294447 H294534 H294604 H294682 H294768 H293917 H294062 H294178 H294292 H294370 H294449 H294535 H294608 H294683 H294770 H293918 H294070 H294179 H294295 H294371 H294450 H294536 H294613 H294684 H294771 H293919 H294081 H294180 H294296 H294373 H294460 H294537 H294614 H294694 H294782 H293925 H294082 H294188 H294297 H294376 H294461 H294538 H294615 H294696 H294786 H293928 H294083 H294190 H294300 H294381 H294465 H294539 H294616 H294697 H294792 H293946 H294087 H294200 H294302 H294382 H294468 H294540 H294618 H294698 H294793 H293947 H294099 H294202 H294303 H294385 H294469 H294541 H294620 H294701 H294796 H293952 H294100 H294203 H294306 H294386 H294470 H294542 H294621 H294705 H294797 H293953 H294102 H294204 H294307 H294387 H294472 H294545 H294623 H294707 H294798 H293954 H294104 H294206 H294311 H294393 H294474 H294546 H294625 H294711 H294801 H293955 H294105 H294207 H294316 H294394 H294476 H294547 H294626 H294712 H294803 H293957 H294106 H294210 H294317 H294395 H294477 H294548 H294630 H294715 H294806 H293960 H294111 H294212 H294319 H294397 H294478 H294549 H294632 H294716 H294807 H293964 H294114 H294213 H294320 H294398 H294479 H294550 H294637 H294719 H294808 H293971 H294118 H294215 H294321 H294401 H294482 H294551 H294640 H294720 H294813 H293981 H294122 H294216 H294322 H294402 H294488 H294552 H294643 H294723 H294815 H293984 H294126 H294219 H294325 H294403 H294493 H294553 H294644 H294724 H294826 H293989 H294128 H294224 H294326 H294404 H294494 H294554 H294645 H294726 H294827 H293993 H294130 H294227 H294329 H294406 H294497 H294556 H294646 H294727 H294829 H294002 H294133 H294232 H294330 H294409 H294498 H294557 H294652 H294728 H294004 H294134 H294238 H294331 H294414 H294499 H294565 H294654 H294729
Reason of Field Safety Corrective Action:A system was discovered where VMAT (Volumetric Modulated Arc Therapy) plans were delivered as Dynamic Arc. it was determined that an older configuration of the Clinac and older version and configuration of the Linac VI software which did not recognize VMAT plans was inadvertently installed.
Remedy Action:Users should observe the C-series display during delivery of a test VMAT plan. The words ‘RapidArc X’ or 'VMAT X' should appear under Treatment Type during dose delivery. If the words ‘RapidArc’ or 'VMAT' are not seen, call Varian service and discontinue use of the device for VMAT treatments. Note you can also determine the version of Linac VI software installed – refer to the 4DITC Administrative Reference Guide. Varian is notifying all affected customers with a FSN. Varian is modifying user documents, installation instructions, and the Customer Acceptance Test Plan in order to prevent a recurrence of this system configuration problem
Athorized Representative/Importer/Distributor:Varian Medical Systems, Riyadh (01) 2772126
Report Source:NCMDR
Source Ref. Number:B3B6BB9FED3B0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Article 1.pdf