Company: Varian Medical Systems, Inc.
Date of Enforcement Report 2/24/2016
Class lI:
PRODUCT
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. Recall Number Z-0805-2016
REASON
When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc.,Palo Alto CA on 1/11/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
9499
DISTRIBUTION
Nationwide and Internationally
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