Device product
Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-0181-2016
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 72424
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154
- Official record key
device-enforcement:Z-0181-2016
Official wording
Reason: Unintended update of Dose and MU and Incorrect Assignment of Bolus.
Code information: Software Version 5.10.01
Distribution pattern: CA, IN, MI,MO, TX, WI, Australia, Canada, Germany,m Greece, India, Netherlands, New Zealand, Turkey and United Kingdom
Derived failure modes
-
Unknown
Unintended update of Dose and MU and Incorrect Assignment of Bolus.