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U.S. Department of Health and Human Services

Class 2 Device Recall Varian Medical Systems VARiS

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 Class 2 Device Recall Varian Medical Systems VARiSsee related information
Date Initiated by FirmJune 24, 2004
Date PostedAugust 07, 2004
Recall Status1 Terminated 3 on December 23, 2004
Recall NumberZ-1314-04
Recall Event ID 29471
Product Classification System, Planning, Radiation Therapy Treatment - Product Code MUJ
Productmedical device and software systems
Code Information Version Numbers 6.2.27 and 6.2.35, 510k number K001643, serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045)
FEI Number 2916710
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
3100 Hansen Way
Palo Alto CA 94304-1028
For Additional Information ContactMark Perkins
650-424-6640
Manufacturer Reason
for Recall		a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
FDA Determined
Cause 2		Other
ActionNotification letter to consignees sent 06/14/2004.
Quantity in Commerce28 units
Distributionprodut was distributed to 28 medical facilities, 12 in the United states, 16 foreign
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.
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