Recall Z-0767-2016 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250 Radiation therapy system
| Date | Feb 8, 2016 (initiated Nov 18, 2015) |
| Status | Terminated |
| Reason | The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment. |
| Root cause | Labeling design |
| Action | Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer. |
| Quantity | 4 |
| Distribution | US nationwide distribution including FL, NJ, OK, and 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 |