Recall Z-2462-2012— Varian Medical Systems, Inc. Oncology Systems

Name: FDA recall Z-2462-2012
Creator: U.S. Food and Drug Administration
Published: 2012-08-17

Class II · Terminated

Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-08-17, terminated 2014-08-06. It names one FDA 510(k) clearance: K102011. Product: Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.. Reason: Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose..

Recalling firm: Varian Medical Systems, Inc. Oncology Systems
Classification: Class II
Status: Terminated
Initiated: 2012-08-17
Terminated: 2014-08-06
Firm location: Palo Alto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102011 — ECLIPSE TREATMENT PLANNING SYSTEMVarian Medical Systems, Inc.·cleared 2010-09-03

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

Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.

Reason for recall

Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.

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