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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 VARiS see related information
Date Initiated by Firm June 24, 2004
Date Posted August 07, 2004
Recall Status1 Terminated 3 on December 23, 2004
Recall Number Z-1314-04
Recall Event ID 29471
Product Classification System, Planning, Radiation Therapy Treatment - Product Code MUJ
Product medical 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)
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
3100 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact Mark 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
Action Notification letter to consignees sent 06/14/2004.
Quantity in Commerce 28 units
Distribution produt was distributed to 28 medical facilities, 12 in the United states, 16 foreign
Total Product Life Cycle TPLC 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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