Device product
Monaco RTP System Radiation treatment planning
Z-2276-2013
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 65996
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45
- Official record key
device-enforcement:Z-2276-2013
Official wording
Reason: Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
Code information: Versions 3.10.00 and later
Distribution pattern: Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
Derived failure modes
-
Unknown
Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.