Recall Z-0411-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy System
| Date | Nov 15, 2016 (initiated Oct 20, 2016) |
| Status | Terminated |
| Reason | Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter |
| Root cause | Software design |
| Action | Mevion issued an Important Safety Notice letter on October 14, 2016 to their customers. The letter identified the affected product, problem, containment, mitigation and actions taken. Customers were informed that Mevion will be updating software when it is released. For further Information, contact: srosenthal@mevion.com. |
| Quantity | 6 units |
| Distribution | US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120676 | S-250 PROTON BEAM RADIATION THERAPY SYSTEM Mevion Medical Systems, Jun 4, 2012 |