Device product
Monaco Product Usage: Planning of radiation therapy
Z-2007-2012
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 62434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-2007-2012
Official wording
Reason: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Code information: Version 3.10.00 - 3.20.00, inclusive
Distribution pattern: US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
Derived failure modes
-
Unknown
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.