Recall Z-0750-2024 ยท IWB System, Radiation Therapy, Radionuclide
Xcision Medical Systems, LLC
GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 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 | Jan 18, 2024 (initiated Nov 30, 2023) |
| Status | Open, Classified |
| Reason | Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected |
| Root cause | Software design |
| Action | Xcision issued Urgent Field Correction Letter via email on 11/30/23. Letter states reason for recall, health risk and action to take: Please post this notification internally for awareness of GammaPod BY CUSTOMER/USER Treatment Planning System users. Xcision is working on an update to the TPS software to implement controls to identify not only the patient identification but also the series of which the structures were delineated. This change is expected for implementation in early 2024. If you need any further information or support concerning this issue, please contact Xcision Customer Suppo |
| Quantity | 4 units |
| Distribution | Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy. |
| FDA record | Open on fda.gov |