Device product
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Z-2277-2013
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 65998
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72
- Official record key
device-enforcement:Z-2277-2013
Official wording
Reason: Patient needs to be positioned as indicated by the treatment plan.
Code information: All versions of Monaco
Distribution pattern: Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
Derived failure modes
-
Unknown
Patient needs to be positioned as indicated by the treatment plan.