Device product
Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Z-0076-2017
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 75303
- Status
- Terminated
- Classification
- Class II
- Quantity
- 365
- Official record key
device-enforcement:Z-0076-2017
Official wording
Reason: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Code information: Software Builds 5.10 and 5.20
Distribution pattern: Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.
Derived failure modes
-
Unknown
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.