Recall Z-2081-2019 ยท IWB System, Radiation Therapy, Radionuclide
Xcision Medical Systems, LLC
GammaPod Stereotactic Radiotherapy System Model A, REF XMSGP030A00-0.02 Product Usage: GammaPod is a teletherapy device intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
| Date | Jul 3, 2019 |
| Status | Terminated |
| Reason | One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent a Field Correction Notice letters dated 7/3/19 to customers. The letter identified the affected product, problem and actions to be taken. If you need any further information or support concerning this issue, please contact Xcsion Customer Support at 855-924-7466. |
| Quantity | 2 |
| Distribution | The products were distributed to the following US states: MD and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180571 | GammaPod Xcision Medical Systems, LLC, Apr 4, 2018 |