Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCLsee related information
Date Initiated by FirmNovember 10, 2011
Date PostedFebruary 03, 2012
Recall Status1 Terminated 3 on February 19, 2015
Recall NumberZ-0945-2012
Recall Event ID 61012
510(K)NumberK990085 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductVarian 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.
Code Information 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     
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information ContactPeter J. Coronado
650-424-5731
Manufacturer Reason
for Recall		Failure to retract or park the Varian MLC leaves prior to use of the demountable BrainLAB m3 could result in the Varian MLC leaves interfering with the treatment field defined by the BrainLAB m3 without an interlock being asserted.
FDA Determined
Cause 2		Device Design
ActionThe firm, Varian Medical Systems, Inc., sent an "URGENT MEDICAL DEVICE CORRECTION-URGENT FIELD SAFETY NOTICE" letter dated November 10, 2011 to all affected users. The letter describes the product, description of problem, details, recommended actions and Varian's actions. Varian Service will contact customers to arrange installation, once modifications are available. ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter also included special instructions for customers outside the USA and Canada. The customers were instructed to complete and return the attached Proof of Notification or Receipt Verification Card to Varian Medical Systems once they have read the document. If you require further clarification, feel fee to contact your local Varian Customer Support District or Regional Manager at: USA and Canada: 1-888-VARIANS (1-888-827-4265); Europe: +41 41 749 8844; or Email: North America: support-americas@varian.com; Australia/New Zealand: support-anz@varian.com; Europe: support-emea@varian.com; South East Asia: support-sea@varian.com; China/Asia: support-china@varian.com; Japan: support-japan@varian.com; Latin America: soporte.al@varian.com or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.
Quantity in Commerce205 units***12-12-12 AMENDED TO: 213 units***
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
-
-