Recall Z-0588-2015 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250, used for proton radiation therapy.
| Date | Dec 12, 2014 (initiated Nov 10, 2014) |
| Status | Terminated |
| Reason | Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%. |
| Root cause | Software design |
| Action | Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email lbouchet@mevion.com or call 978-540-1555. |
| Quantity | 1 |
| Distribution | US 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 |