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U.S. Department of Health and Human Services

Class 2 Device Recall Varian RPM System version 1.7.3

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  Class 2 Device Recall Varian RPM System version 1.7.3 see related information
Date Initiated by Firm September 26, 2007
Date Posted January 29, 2008
Recall Status1 Terminated 3 on September 30, 2009
Recall Number Z-0554-2008
Recall Event ID 45519
510(K)Number K063270  
Product Classification Linear Medical Accelerator - Product Code IYE
Product Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models; Varian Medical Systems, Palo Alto, CA 94304
Code Information Serial Number:  H502244, H502211, H502203, H502183, H502179, H502178, H502169, H502167, H502166, H502154, H502152, H502138, H502137, H502136, H502133, H502132, H502131, H502130, H502126, H502121, H502119, H502118, H502117, H502116, H502112, H502110, H502107, H502104, H502103, H502102, H502096, H502060, H502057, H502045, H502002, H501999, H501983, H501930, H501907, H501904, H501869, H501838, H501577, H501412, H501367, H501329, H501325, H501306, H501290, H501259, H501246, H501222, H501214, H502051, H502067, H500395, H500406, H500853, and H502066   
Recalling Firm/
Manufacturer		 Varian Medical Systems Inc
911 Hansen Way
Palo Alto CA 94304
For Additional Information Contact Dale Reynolds
650-424-6640
Manufacturer Reason
for Recall		 Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered
FDA Determined
Cause 2		 Software design
Action Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.
Quantity in Commerce 59 units
Distribution Worldwide including countries of: Ireland, Italy, Spain, UK, Denmark, Finland, France, and Canada
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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