FDAFDA · Alimentos y medicamentos·N.º oficial Z-0439-2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Publicado el 11 de diciembre de 2013 · Inicio del retiro: 24 de octubre de 2013
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
This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Varian Medical Systems, Inc.
- Distribuidor
- Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe.
- Lote
- Model numbers Hl4, HIS, H27, H29: Serial numbers: H140001 H140136 H140700 H140759 Hl40817 H140875 Hl40937 H140995 Hl82047 H271330 H271664 H271935 H272132 H140011 Hl40137 H140701 H140760 Hl40818 H140876 Hl40938 H140996 Hl82048 H271334 H271666 H271938 H272134 H140018 H140138 Hl40702 H140761 Hl40819 Hl40877 H140939 H140997 Hl82049 H271344 H271669 H271942 H272136 Hl40025 H140139 Hl40703 Hl40762 Hl40820 H140878 H140940 Hl40998 Hl82050 H271362 H271678 H271951 H272137 Hl40026 H140140 Hl40704 Hl40763 H140821 H140879 H140941 H140999 Hl820Sl H271370 H271681 H271954 H272138 Hl40027 Hl40141 Hl40705 Hl40764 H140822 Hl40880 H140942 Hl41000 Hl82054 H271378 H271691 H271958 H272143 H140029 H140142 Hl40706 Hl4076S H140823 H140881 H140943 Hl41001 Hl820SS H27138S H271693 H271959 H272144 Hl40036 H140143 Hl40707 Hl40766 H140824 H140882 H140944 H141002 H182056 H271393 H271711 H271961 H27214S H140038 H140144 H140708 H140767 H14082S H140883 H14094S H141003 Hl82057 H271398 H271712 H271964 H272146 H140039 H14014S H140709 H140768 H140826 H140884 H140946 H141004 Hl82058 H271407 H271713 H271966 H272150 H140043 H140146 H140710 H140769 H140827 H14088S H140947 H141005 Hl82060 H271413 H271714 H271972 H272153 Hl4004S H140147 H140711 H140770 Hl40828 H140886 H140948 H141007 H182061 H271414 H271724 H271973 H272155 Hl40046 H140148 H140712 H140771 H140829 H140888 H140949 H141009 H182062 H271420 H271729 H271974 H272156 H140047 H140150 H140713 H140772 H140830 H140889 H1409SO H141010 Hl82063 H271425 H271742 H271975 H272157 H140048 H140151 H140714 H140773 H140831 H140890 H140951 H141011 H182064 H271429 H271755 H271987 H272158 H140058 H140152 H140715 Hl40774 H140832 H140891 H140952 H141015 H182066 H271438 H271760 H271993 H272159 H140062 H140153 Hl40716 H140775 H140833 H140892 H140953 H141017 Hl82067 H271439 H271762 H271994 H272162 H140067 H140154 H140717 H140776 H140834 H140893 H140954 H141022 Hl82068 H271443 H271763 H272001 H272163 Hl40069 Hl40201 H140718 H140777 H140835 H140895 H140955 H182000 Hl82072 H271452 H271773 H272003 H272168 H140070 H140202 Hl40719 H140778 H140836 H140896 H140956 H182001 Hl82073 H271459 H271780 H272009 H272169 H140071 H140203 Hl40720 Hl40779 H140837 Hl40897 H140957 Hl82002 H182077 H271478 H271783 H272014 H272172 H140074 Hl40204 H140721 H140780 H140838 Hl40900 H140958 H182003 H182078 H271490 H271785 H272016 H272173 H140076 H140205 H140722 H140781 Hl40839 Hl40901 H140959 Hl82004 H182079 H271497 H271787 H272018 H272174 H140077 H140206 H140723 H140782 Hl40840 Hl40902 Hl40960 Hl82005 H182080 H271500 H271801 H272022 H272178 H140078 H140207 Hl40724 H140783 Hl40841 H140903 Hl40961 Hl82006 H182082 H271502 H271802 H272023 H272179 H140079 H140208 H140725 H140784 Hl40842 H140904 H140962 Hl82007 Hl82084 H271507 H271808 H272024 H272180 H140086 Hl40209 H140726 H140785 Hl40843 H140905 Hl40963 Hl82008 H182086 H271512 H271809 H272027 H272181 H140088 H140210 H140727 H140786 H140844 H140906 H140964 Hl82009 Hl82200 H271515 H271815 H272029 H272187 H140090 Hl40211 Hl40728 H140787 H140845 H140907 H140965 Hl82010 Hl82201 H271516 H271825 H272032 H272188 Hl40092 H140212 H140729 H140788 H140846 H140908 H140966 H182011 Hl82202 H271519 H271828 H272033 H272195 H140096 H140213 H140730 H140789 H140847 H140909 H140967 H182012 Hl82203 H271523 H271833 H272035 H272197 H140097 H140214 H140731 H140790 H140848 H140910 H140968 Hl82013 Hl82204 H271526 H271834 H272038 H272198 Hl40098 H140215 H140732 H140791 H140849 H140911 H140969 H182014 Hl82205 H271531 H271835 H272043 H272201 H140101 H140216 H140733 H140792 H140850 H140912 H140970 Hl82015 H182206 H271534 H271836 H272045 H272202 H140103 H140217 H140734 H140793 H140851 H140913 H140971 H182016 Hl82208 H271550 H271838 H272049 H272203 H140106 H140218 Hl4073S Hl40794 H140852 H140914 H140972 H182017 H182209 H271551 H271843 H272050 H272204 Hl40107 H140219 H140736 Hl40795 Hl40853 Hl40915 H140973 H182018 H182210 H271557 H271845 H272051 H272209 H140108 H140220 H140737 Hl40796 H140854 H140916 H140974 H1
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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