Z-0945-2012

Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3...

Name: Z-0945-2012 Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3...
Creator: Varian Medical Systems, Inc. Oncology Systems
Published: 2011-11-10
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2011-11-10 / Terminated / root cause: design

FDA source

Varian Medical Systems, Inc. Oncology Systems began a recall of Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53... on 2011-11-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0945-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-02-03
Terminated: 2015-02-19
Recalling firm: Varian Medical Systems, Inc.
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: design
FDA root cause: Device Design
Action: The 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: [email protected]; Australia/New Zealand: [email protected]; Europe: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected]; Latin America: [email protected] or Internet: Oncology Systems customer site-www.myvarian.com and Varian Medical Systems public site-www.varian.com.
Quantity in commerce: 205 units***12-12-12 AMENDED TO: 213 units***
Distribution: 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.
Product codes and lots: 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

Product code IYE

K990085Class IIMillennium Mlc -120Varian Assoc., Inc. / cleared 1999-02-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)