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U.S. Department of Health and Human Services

Class 2 Device Recall VARiS PRT Exchange

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  Class 2 Device Recall VARiS PRT Exchange see related information
Date Initiated by Firm October 02, 2007
Date Posted February 15, 2008
Recall Status1 Terminated 3 on May 17, 2011
Recall Number Z-0720-2008
Recall Event ID 45527
510(K)Number K001643  
Product Classification Linear Medical Accelerator - Product Code IYE
Product Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Alto, CA
Code Information Serial Numbers: All
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact
650-424-5731
Manufacturer Reason
for Recall		 Incorrect Software Validation- The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.
FDA Determined
Cause 2		 Software design
Action An Urgent Medical Device Correction letter was distributed October 2, 2007, to all direct consignees, informing them that the ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery will not be recognized properly by the System. The firm provided corrective instructions and informed consignees that a product modification will be developed to resolve the issue. A Varian Service Representative will be scheduling a visit to upgrade the application.
Distribution Worldwide Distribution
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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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