Recall Z-0805-2016— Varian Medical Systems, Inc.

Name: FDA recall Z-0805-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-11

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc., initiated 2016-01-11, terminated 2017-10-25. It names one FDA 510(k) clearance: K152393. 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.. 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: Varian Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-11
Terminated: 2017-10-25
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152393 — Eclipse Treatment Planning SystemVarian Medical Systems, Inc.·cleared 2015-09-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.