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Recall / Field Safety Notice

mdprc 115 07 13 000

2013-07-17

Saudi Arabia

SFDA

https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3981

Sample couch parameter files are supplied with monaco releases 3.10.00 and later. the user can access these files from the treatment couch library. by clicking on a particular couch file, the individual components of the couch can be selected and their densities edited. the user can then use the “save as treatment couch” to enter a unique name for the modified couch parameter file. the sample files and their default values are not intended for clinical use, and monaco was designed with the assumption that the user would rename the file when it was populated with actual, clinical values. when sample couch parameter files are edited, the densities altered, and “save” is selected, the sample files will be updated with these new, user defined densities. subsequently, when a software upgrade is loaded, under the conditions described below, the modified couch densities in these sample files will be overwritten with the default value of 1.000. this problem will affect upgrades to monaco releases 3.20.00 and 3.30.00 from release 3.10.00 or 3.20.00. the problem will occur during an upgrade if and only if – prior to the upgrade – a sample couch parameter file was edited and saved under the original name. the problem occurs because the upgrade installation script is designed to overwrite the sample couch files in the treatment couch library with the original default values.