Class 2 Device Recall Varian RPM System version 1.7.3

• Date Initiated by Firm: September 26, 2007
• Date Posted: January 29, 2008
• Recall Status: Terminated 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
• FEI Number: 2916710
• 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: 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