Recall Z-0410-2017 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 21, 2016) |
| Status | Terminated |
| Reason | Recovery of Incorrect Isocenter -operational change |
| Root cause | Software Design Change |
| Action | Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at rcessac@mevion.com or by phone at (978) 540-1501. |
| Quantity | 6 units |
| Distribution | US Nationwide Distribution in the states of FL, MO, NJ, OH and 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 |