FDAFDA · Food and drugs·Recall number Z-1325-2013
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Published May 22, 2013 · Recall initiated: May 31, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc. Oncology Systems
- Distributor
- Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria, Canada, Chile, China, Columbia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Frances, French Polynesia, Georgia, Germany, Greece, Gaudaloupe, Gaum, Hong Kong, India, Indonesia, Ireland, Italy, Israel, Latvia, Lithuania, Luxemburg, Japan, Kazarhstan, Kuwait, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morroco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Phillipines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Syria, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezula, Vietnam, and Zimbabwe.
- Lot
- CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H140002 H140065 H140139 H140723 H140797 H140863 H260949 H270271 H270430 H270540 H270709 H270829 H271018 H140003 H140066 H140141 H140724 H140798 H140865 H260950 H270273 H270431 H270542 H270710 H270833 H271019 H140004 H140067 H140143 H140725 H140799 H140866 H260951 H270277 H270435 H270544 H270711 H270836 H271020 H140005 H140068 H140144 H140726 H140800 H140868 H260952 H270280 H270437 H270547 H270712 H270837 H271021 H140006 H140069 H140145 H140727 H140801 H140869 H260953 H270281 H270438 H270550 H270714 H270838 H271023 H140007 H140070 H140146 H140729 H140803 H140871 H270004 H270282 H270439 H270601 H270716 H270840 H271024 H140008 H140071 H140147 H140731 H140804 H140872 H270006 H270285 H270443 H270602 H270718 H270841 H271026 H140009 H140073 H140148 H140733 H140805 H140873 H270009 H270290 H270445 H270607 H270719 H270842 H271031 H140010 H140074 H140150 H140734 H140806 H140874 H270010 H270293 H270446 H270613 H270725 H270844 H271032 H140011 H140075 H140151 H140737 H140807 H140877 H270021 H270297 H270447 H270615 H270726 H270845 H271034 H140012 H140077 H140152 H140738 H140808 H140878 H270026 H270302 H270448 H270622 H270727 H270846 H271035 H140014 H140078 H140153 H140739 H140809 H140879 H270027 H270303 H270451 H270623 H270728 H270852 H271037 H140015 H140080 H140154 H140740 H1408095 H140882 H270029 H270307 H270452 H270624 H270732 H270854 H271038 H140016 H140082 H140201 H140742 H140810 H140883 H270030 H270310 H270454 H270625 H270733 H270855 H271039 H140017 H140083 H140202 H140743 H140811 H140885 H270038 H270314 H270455 H270627 H270735 H270857 H271041 H140018 H140084 H140203 H140744 H140812 H140886 H270045 H270323 H270458 H270631 H270736 H270858 H271043 H140019 H140086 H140204 H140745 H140813 H140889 H270047 H270324 H270461 H270632 H270737 H270859 H271044 H140021 H140088 H140206 H140746 H140814 H140890 H270073 H270329 H270462 H270633 H270739 H270861 H271051 H140022 H140090 H140207 H140747 H140815 H140891 H270079 H270332 H270464 H270634 H270740 H270863 H271052 H140023 H140092 H140208 H140748 H140816 H140892 H270088 H270335 H270466 H270635 H270746 H270864 H271055 H140024 H140093 H140209 H140749 H140817 H140893 H270094 H270337 H270470 H270637 H270749 H270865 H271056 H140025 H140095 H140210 H140750 H140819 H140896 H270096 H270338 H270473 H270639 H270751 H270866 H271059 H140026 H140096 H140212 H140751 H140820 H140897 H270101 H270341 H270474 H270641 H270752 H270867 H271061 H140027 H140097 H140213 H140754 H140822 H140907 H270106 H270344 H270476 H270643 H270755 H270868 H271062 H140028 H140098 H140214 H140755 H140823 H140908 H270107 H270345 H270477 H270644 H270757 H270869 H271063 H140029 H140099 H140215 H140756 H140824 H140909 H270110 H270351 H270479 H270645 H270762 H270870 H271066 H140030 H140100 H140217 H140757 H140825 H140914 H270111 H270352 H270482 H270646 H270766 H270871 H271068 H140032 H140101 H140218 H140758 H140826 H140917 H270118 H270353 H270483 H270647 H270767 H270872 H271071 H140033 H140102 H140219 H140760 H140827 H140918 H270126 H270355 H270486 H270648 H270769 H270873 H271072 H140034 H140103 H140220 H140761 H140828 H140919 H270128 H270356 H270487 H270649 H270777 H270875 H271075 H140035 H140105 H140222 H140762 H140829 H140920 H270134 H270360 H270489 H270651 H270781 H270877 H271076 H140036 H140106 H140223 H140764 H140830 H140921 H270136 H270364 H270490 H270652 H270782 H270878 H271079 H140037 H140107 H140228 H140765 H140834 H140922 H270138 H270365 H270491 H270653 H270783 H270879 H271080 H140038 H140108 H140229 H140766 H140835 H140925 H270144 H270370 H270495 H270654 H270785 H270880 H271082 H140039 H140110 H140231 H140767 H140836 H140927 H270201 H270371 H270498 H270656 H270786 H270881 H271083 H140040 H140111 H140232 H140768 H140838 H140928 H270209 H270373 H270499 H270660 H270787 H270882 H271085 H140041 H140113 H140233 H140769 H140839 H140934 H270211 H270378 H270500 H270661 H270788 H270883 H271086
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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