Recall Z-2406-2020 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Mevion Medical Systems, Inc.
MEVION S250i, MEVION S250; Proton Radiation Treatment System
| Date | May 15, 2020 |
| Status | Terminated |
| Reason | Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off |
| Root cause | Software design |
| Action | Mevion issued letter (pCAR0012) on May 15, 2020 via mail or FedEx, with return receipt confirmation. Letter states reason for recall, health risk and action to take: Until a software fix is applied for this problem, the user is cautioned to carefully pay attention to the 3 indicators of Couch corrections. If they disagree with the intended moves the user may simply repeat the alignment step and the problem should clear. Required User Action When using multimodal imaging the user should always check the indicators for Couch Corrections before they are applied. This includes the Verity Couch Cor |
| Quantity | 8 units |
| Distribution | Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands |
| FDA record | Open on fda.gov |