Recall Z-1237-2015 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta, Inc.
Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
| Date | Mar 2, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | Incorrect CT to ED when using the Monaco Image Statistics Tool. |
| Root cause | Other |
| Action | Elekta sent an Important User Notice on December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice provided a workaround until new software releases. The notice included a acknowledgement form to be returned. For further questions please call (770) 300-9725 |
| Quantity | 1354 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Au |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132971 | MONACO Impac Medical Systems, Inc., Nov 20, 2013 |