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U.S. Department of Health and Human Services

Class 2 Device Recall Varian RV Software

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 Class 2 Device Recall Varian RV Softwaresee related information
Date Initiated by FirmJune 02, 2008
Date PostedOctober 22, 2008
Recall Status1 Terminated 3 on May 03, 2011
Recall NumberZ-0164-2009
Recall Event ID 48661
510(K)NumberK001643 
Product Classification Medical Linear Accelerator - Product Code IYE
ProductVarian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan.
Code Information H462082, H463052, H462031, H463016, H462001, H462075, H462079, H462005, H462006, H462016, H462017, H462021, H462022, H462023, H462024, H463024, H463377, H463017.    
FEI Number 2916710
Recalling Firm/
Manufacturer		 Varian Medical Systems Oncology Systems
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		A malfunction within the Varis software might result in a misadministration (underdose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
FDA Determined
Cause 2		Software design
ActionRecall initiated on June 2, 2008. A product notification letter was distributed by certified mail to all affected consignees.
Quantity in Commerce18
DistributionWorldwide Distribution --- including USA and countries of Canada, Austria, France, Germany, South Korea, Sweden, and the UK.
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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