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U.S. Department of Health and Human Services

Class 2 Device Recall VARiS Version 6.6

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 Class 2 Device Recall VARiS Version 6.6see related information
Date Initiated by FirmSeptember 20, 2005
Date PostedAugust 05, 2006
Recall Status1 Terminated 3 on November 21, 2006
Recall NumberZ-1375-06
Recall Event ID 35886
510(K)NumberK050479 
Product Classification Accelerator, Linear, Medical - Product Code IYE
ProductVaris Vision Treatment 6.6/RTP Exchange/Siemens Accelerators
Code Information H462074, H462000, H462003, H462004, H462005, H462006, H462011, H462012, H462013, H462014, H462015, H462016, H462017, H462018, H462019, H462020, H462021, H462022, H462023, H462024, H462025, H462026, H462027, H462028, H462029, H462031, H462040, H462045, H462047, H462048, H462049, H462050, H462051, H462052, H462054, H462055, H462057, H462059, H462060, H462061, H462064, H462065, H462066, H462067, H462068, H462072, H462073, H462075, H462076, H462077, H462079, H462082, H462083, H462084, H462085, H462086, H462087
Recalling Firm/
Manufacturer		 Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
Manufacturer Reason
for Recall		A software anomaly may occur which can lead to patient treatment with the wrong field. The anomaly is reported only to occur when this software version (6.6.5022) is used with Elekta or Siemens linear accelerators .
FDA Determined
Cause 2		Software design
ActionOn 09/20/2005, Varian Medical Systems issued a notification letter via certified mail and FedEx. These letters were issued with instructions on what to do regarding the corrections. Varian Medical Systems intends to release new, updated software.
Quantity in Commerce58 units
DistributionThe product was distributed to 34 consignees, located in AZ, CA, MA, MI, NC, PA in the USA, and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Lithuania, Spain, Sweden, and the United Kingdom
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
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