GammaPod Stereotactic Radiotherapy System Model A, REF… recallZ-2081-2019 · Xcision Medical Systems, LLC · initiated Jul 3, 2019
Terminated
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
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2081-2019
- Status
- Terminated
- Initiated by the company
- Jul 3, 2019
- Recalling firm
- Xcision Medical Systems, LLC
- Quantity
- 2
- Product code
- IWB
- FDA submissions
- K180571
- Distribution
- The products were distributed to the following US states: MD and TX.
Product description
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.
Code information (models, lots, serial numbers)
Serial Numbers GP0002, GP0004; UDI: (01) 00850002615005
Devices named in this recall
1 device 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
Other devices under the same FDA submission
1 device cleared under K180571 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 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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