Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
FDA Recall Z-0181-2016 · Posted 2015-10-30
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2015-10-16
Date Terminated2017-04-04
Product Quantity154
Reason for Recall
Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Firm Action
Elekta sent Important Field Safety Notice 382-01-MON-003 to all customers on 10/16/2015. The notice informs users of the specific product and version numbers affected by both issues. The affected devices for both issues are those running Monaco 5.10.01. Customers are instructed to complete and return acknowledgement form. Solution/fix has been released in Monaco patch 5.10.02 and all affected users will be made aware of its availability by the end of October 2015.
Root Cause
Other
Distribution Pattern
CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.