Recall Z-2007-2012 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco Product Usage: Planning of radiation therapy
| Date | Jul 12, 2012 (initiated Jun 21, 2012) |
| Status | Terminated |
| Reason | Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports. |
| Root cause | Software design |
| Action | Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available. |
| Quantity | 38 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |