FDAFDA · Food and drugs·Recall number Z-2567-2014
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Published September 24, 2014 · Recall initiated: June 17, 2014
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
Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Varian Medical Systems, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Byelarus, Belgium, Bosniak, Brazil;, Bulgaria, Burma, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Luxembourg, Macau, Macedonia, Malaysia, Mauritania, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia,, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
- Lot
- Model numbers HCX, H14, H27, H29. Serial numbers: H140001 H140152 H140724 H140791 H140857 H140924 H140985 H271272 H271729 H272009 H272180 H272353 H272819 H140011 H140201 H140725 H140792 H140858 H140925 H140986 H271276 H271755 H272014 H272181 H272354 H272820 H140018 H140202 H140727 H140793 H140859 H140926 H140987 H271293 H271759 H272015 H272187 H272359 H272822 H140025 H140203 H140728 H140795 H140860 H140927 H140988 H271308 H271762 H272016 H272188 H272362 H272824 H140026 H140204 H140729 H140796 H140861 H140928 H140989 H271330 H271763 H272018 H272195 H272365 H272825 H140027 H140206 H140730 H140797 H140863 H140930 H140990 H271334 H271773 H272022 H272197 H272370 H272826 H140029 H140207 H140732 H140799 H140864 H140931 H140991 H271385 H271783 H272023 H272198 H272377 H272828 H140036 H140208 H140733 H140800 H140865 H140932 H140992 H271400 H271785 H272024 H272201 H272382 H272834 H140038 H140209 H140734 H140801 H140866 H140933 H140993 H271407 H271787 H272027 H272202 H272388 H272837 H140039 H140210 H140735 H140802 H140867 H140934 H140994 H271413 H271802 H272029 H272204 H272391 H272841 H140045 H140211 H140736 H140803 H140868 H140935 H140995 H271414 H271809 H272032 H272209 H272394 H272846 H140046 H140213 H140737 H140804 H140869 H140936 H140996 H271420 H271815 H272035 H272212 H272397 H272847 H140047 H140214 H140738 H140805 H140870 H140937 H140997 H271438 H271825 H272038 H272216 H272401 H272848 H140048 H140215 H140742 H140806 H140871 H140938 H140998 H271439 H271828 H272043 H272219 H272405 H272849 H140058 H140216 H140743 H140807 H140872 H140939 H140999 H271443 H271833 H272045 H272220 H272408 H272851 H140062 H140217 H140744 H140808 H140874 H140940 H141000 H271452 H271834 H272049 H272223 H272410 H272852 H140067 H140218 H140745 H140809 H140875 H140941 H141002 H271459 H271835 H272050 H272226 H272413 H272854 H140070 H140219 H140747 H140810 H140876 H140942 H141003 H271490 H271838 H272051 H272231 H272415 H272856 H140071 H140220 H140748 H140811 H140877 H140943 H141004 H271497 H271843 H272052 H272235 H272418 H272857 H140072 H140221 H140749 H140812 H140878 H140944 H141005 H271500 H271845 H272062 H272236 H272421 H272858 H140076 H140222 H140750 H140813 H140879 H140945 H141007 H271502 H271853 H272064 H272237 H272422 H272859 H140077 H140223 H140751 H140816 H140880 H140946 H141008 H271507 H271856 H272069 H272239 H272423 H272862 H140078 H140224 H140752 H140817 H140881 H140947 H141009 H271512 H271858 H272077 H272240 H272425 H272864 H140079 H140225 H140753 H140818 H140882 H140948 H141010 H271515 H271862 H272078 H272241 H272426 H272865 H140086 H140226 H140754 H140819 H140883 H140949 H141011 H271516 H271866 H272079 H272250 H272427 H272867 H140090 H140227 H140755 H140820 H140884 H140950 H141012 H271519 H271867 H272081 H272259 H272428 H272872 H140092 H140228 H140756 H140821 H140885 H140951 H141013 H271526 H271870 H272085 H272260 H272432 H272873 H140096 H140229 H140757 H140822 H140888 H140952 H141015 H271531 H271872 H272086 H272271 H272438 H272880 H140097 H140230 H140758 H140823 H140889 H140953 H141016 H271534 H271879 H272089 H272283 H272440 H272884 H140098 H140231 H140760 H140824 H140890 H140954 H141017 H271550 H271881 H272094 H272284 H272441 H272885 H140101 H140232 H140761 H140826 H140891 H140955 H141018 H271569 H271893 H272096 H272290 H272444 H272888 H140103 H140233 H140762 H140827 H140892 H140956 H141019 H271571 H271896 H272111 H272291 H272445 H272889 H140106 H140234 H140763 H140829 H140893 H140957 H141020 H271575 H271903 H272115 H272293 H272446 H272890 H140109 H140235 H140765 H140830 H140895 H140958 H141021 H271588 H271905 H272117
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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