GammaPod - Treatment Planning System-a component of the GammaPod Irradiation System. Ref: XMSGP030A09.07-0.01 Intended f
FDA device recall Z-0750-2024 · posted 2024-01-18 · Open, Classified
Recall details
- Recalling firm
- Xcision Medical Systems, LLC
- Reason for recall
- Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
- Action taken
- 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 Support at 855-924-7466 (1-855- SUPPORT XCISION).
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- IWB
- Quantity affected
- 4 units
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
- Date initiated
- 2023-11-30
- Date posted
- 2024-01-18
- Location
- Columbia, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GammaPod (K180571) | Xcision Medical Systems, LLC | 2018-04-04 |
| GammaPod - Model A (K172706) | Xcision Medical Systems, LLC | 2017-12-22 |