Recall Z-2462-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Varian Medical Systems, Inc. Oncology Systems
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 irrad
| Date | Sep 26, 2012 (initiated Aug 17, 2012) |
| Status | Terminated |
| Reason | Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the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. |
| Root cause | Software design |
| Action | VARIAN Medical Systems sent an Urgent Medical Device Correction Urgent Field Safety Notice on August 17, 2012, to all affected customers with a description of the problem and user corrective action steps. Customers were instructed to ensure that the workstation clock be synchronized with the DatabaseSystem server clock. Customers were also instructed to contact Varian service for assistance with time synchronization if required. Customers were to complete the attached Proof of Notification Form once they have read the document and return it to Varian Medical Systems. For questions custome |
| Quantity | 6087 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally. . . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102011 | ECLIPSE TREATMENT PLANNING SYSTEM Varian Medical Systems, Inc., Sep 3, 2010 |