Recall Z-0409-2017 ยท MUJ System, Planning, Radiation Therapy Treatment
Mevion Medical Systems, Inc.
MEVION S250 Product Usage: Proton Radiation Therapy
| Date | Nov 15, 2016 (initiated Oct 31, 2016) |
| Status | Terminated |
| Reason | Completing Setup Without Program Move Complete Can Cause An Isocenter Error |
| Root cause | Software design |
| Action | Mevion issued an Important Safety Notice letter on October 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com |
| Quantity | 6 units |
| Distribution | US Nationwide in the states of FL, MO, NJ 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 |