Recall Z-2276-2013 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco RTP System Radiation treatment planning
| Date | Sep 25, 2013 (initiated Jul 2, 2013) |
| Status | Terminated |
| Reason | Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values. |
| Root cause | Device Design |
| Action | Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, mak |
| Quantity | 45 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc., Jun 24, 2011 |