Device product
Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Z-0112-2016
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 72221
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154 units
- Official record key
device-enforcement:Z-0112-2016
Official wording
Reason: Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Code information: Software Version 5.10.00
Distribution pattern: Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
Derived failure modes
-
Unknown
Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.