Varian brand Eclipse Treatment Planning System 의 리콜

Recall

63093

Class 2

Z-2462-2012

2012-08-17

2012-09-26

Terminated

United States

2014-08-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112531

Varian has identified an anomaly with the eclipse treatment planning where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the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.

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 customers should call the following numbers: USA and Canada 1-888-827-4265. Europe +41 41 749 8844. For questions regarding this recall call 650-424-5731.