U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Upgrade installation script is designed to overwrite the same pouch files in the treatment couch library with the original default values.
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Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, make the necessary updates to the couch parameters, and use the "Save As Treatment Couch" option to save the modified sample couch files to a new, unique name.
Please note that the couch files can also be edited in Focal and then the patients opened in Monaco. Comparable Focal releases would be Focal4.64.00(Monaco 3.10.00), Focal4.70.00(Monaco
3.20.00) and Focal4.80.00 (Monaco 3.30.00).
For questions regarding this recall call 404-993-5886.