Recall Z-1271-2014 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
| Date | Mar 22, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields |
| Root cause | Software design |
| Action | Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555. |
| Quantity | 1 unit |
| Distribution | USA Nationwide Distribution in the state of MO |
| 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 |