Recall Z-1122-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
| Date | Feb 2, 2017 (initiated Dec 16, 2016) |
| Status | Terminated |
| Reason | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened |
| Root cause | Software design |
| Action | Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com. |
| Quantity | 2 units |
| Distribution | US Nationwide in the states of OK, NJ |
| 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 |