Recall Z-2560-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given
| Date | Sep 4, 2019 |
| Status | Open, Classified |
| Reason | It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation. |
| Root cause | Software design |
| Action | The firm notified their consignees of the issue by email on 09/04/2019. The letter explained the problem and the workaround and requested the notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and that all appropriate personnel working with the product be advised of the content of the letter. |
| Quantity | 30 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of WI, OH, NY, OH, IN, IA, TX, and countries of Canada, China, Denmark, Germany, Greece, Hong Kong, Italy, Netherlands, Sweden, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183037 | Monaco RTP System Elekta, Inc., Dec 4, 2018 |