Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL

H530001 ,H530075 ,H530439 ,H533043 ,H535023 ,H535082 ,H535128 ,H535180 ,H535220 ,H530004 ,H530078 ,H531008 ,H534004 ,H535024 ,H535084 ,H535131 ,H535181 ,H535867 ,H530008 ,H530082 ,H531010 ,H534015 ,H535025 ,H535085 ,H535133 ,H535182 ,H536005 ,H530012 ,H530084 ,H531020 ,H534020 ,H535030 ,H535086 ,H535135 ,H535183 ,H536452 ,H530014 ,H530085 ,H531025 ,H534021 ,H535031 ,H535087 ,H535137 ,H535184 ,H536465 ,H530018 ,H530087 ,H531029 ,H534022 ,H535033 ,H535088 ,H535141 ,H535186 ,H536479 ,H530021 ,H530104 ,H531033 ,H534026 ,H535035 ,H535091 ,H535142 ,H535188 ,H530022 ,H530204 ,H531035 ,H534032 ,H535036 ,H535094 ,H535144 ,H535190 ,H530023 ,H530231 ,H531038 ,H534036 ,H535039 ,H535098 ,H535147 ,H535191 ,H530024 ,H530250 ,H531041 ,H534040 ,H535043 ,H535099 ,H535149 ,H535192 ,H530030 ,H530311 ,H531043 ,H534223 ,H535044 ,H535100 ,H535151 ,H535193 ,H530034 ,H530323 ,H531044 ,H535003 ,H535045 ,H535104 ,H535154 ,H535194 ,H530035 ,H530339 ,H532005 ,H535004 ,H535046 ,H535105 ,H535157 ,H535195 ,H530036 ,H530340 ,H532006 ,H535005 ,H535047 ,H535106 ,H535159 ,H535197 ,H530045 ,H530396 ,H532014 ,H535008 ,H535053 ,H535108 ,H535161 ,H535199 ,H530046 ,H530401 ,H532021 ,H535009 ,H535054 ,H535109 ,H535162 ,H535200 ,H530049 ,H530405 ,H532027 ,H535012 ,H535055 ,H535111 ,H535164 ,H535201 ,H530050 ,H530417 ,H533004 ,H535013 ,H535056 ,H535115 ,H535166 ,H535207 ,H530051 ,H530423 ,H533008 ,H535014 ,H535058 ,H535116 ,H535167 ,H535209 ,H530055 ,H530425 ,H533014 ,H535015 ,H535068 ,H535117 ,H535168 ,H535211 ,H530057 ,H530427 ,H533027 ,H535016 ,H535070 ,H535120 ,H535169 ,H535213 ,H530063 ,H530428 ,H533028 ,H535017 ,H535072 ,H535121 ,H535173 ,H535214 ,H530064 ,H530429 ,H533029 ,H535018 ,H535073 ,H535122 ,H535176 ,H535215 ,H530066 ,H530430 ,H533036 ,H535020 ,H535076 ,H535123 ,H535177 ,H535218 ,H530068 ,H530433 ,H533037 ,H535021 ,H535081 ,H535124 ,H535178 ,H535219,  ***12-12-12, AMENDED INFO ***: ,H513353 ,H51B100 ,H514449 ,H51B240 ,H517726 ,H51B242 ,H51B083 ,H51B320

Radiology Devices

2

No

Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Algeria, Austria, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Slovenia, South Korea, Spain, Sri Lanka, Sweden, Taiwan, Turkey, United Kingdom and Venezuela.

Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA || Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.