GammaPod - Treatment Planning System-a component of the… recallZ-0750-2024 · Xcision Medical Systems, LLC · initiated Nov 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Xcision Medical Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
FDA root cause category: Software design
What the company is doing
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).
Recall details
- Recall number
- Z-0750-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Xcision Medical Systems, LLC
- Quantity
- 4 units
- Product code
- IWB
- FDA submissions
- K172706, K180571
- Distribution
- Worldwide - US Nationwide distribution in the states of MD, PA, TX and the country of Italy.
Product description
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.
Code information (models, lots, serial numbers)
00850002615029(11)230321(21)TPS0018 (Distributed in the US) 00850002615029(11)230629(21)TPS0013 (Distributed in the US) 00850002615005(11)21H24(21)TPS0016 (Distributed in the US) 00850002615029(11)210629(21 )TPS0014 (Italy)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- GammaPod™ Model AXcision Medical Systems, LLC · System, Radiation Therapy, Radionuclide2 recalls0 reports
- GammaPod™ Treatment Planning System Model AXcision Medical Systems, LLC · System, Radiation Therapy, Radionuclide1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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