Recall Z-2277-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
| Date | Sep 25, 2013 (initiated May 22, 2013) |
| Status | Terminated |
| Reason | Patient needs to be positioned as indicated by the treatment plan. |
| Root cause | Labeling design |
| Action | Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom. |
| Quantity | 72 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |