Cl ll TrueBeam and True Beam STx versions

Company:Varian Medical Systems, Inc.
Date of Enforcement Report 5/30/12
Class ll:

PRODUCT
TrueBeam and True Beam STx versions 1.0 through 1.5, Model number H19; TrueBeam Radiotherapy Delivery System is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Recall # Z-1175-2012

REASON
An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during planning.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter on January 30, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
182 units

DISTRIBUTION
Nationwide and Internationally

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Software Verification

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.