Company: Varian Medical Systems, Inc.
Date of Enforcement Report 5/23/12
Class ll:
PRODUCT
True Beam; Versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below. Product Usage: TrueBeam Radiotherapy delivery system is intended to provide sterotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. Model number H19. Recall # Z-1495-2012
REASON
A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letter dated April 13, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
207 devices
DISTRIBUTION
Nationwide and Internationally
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