GammaPod™ Model ARecalls & reported problems
Xcision Medical Systems, LLC · Stereotactic Radiotherapy System · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Nov 30, 2023Open, Classified
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Z-0750-2024 · Root cause: Software design · FDA record ↗
- Jul 3, 2019Terminated
One bolt on the V motor was not fully tightened which caused a drift of .13 degrees in alignment resulting in reduced dose output.
Z-2081-2019 · Root cause: Nonconforming Material/Component · FDA record ↗
Other System, Radiation Therapy, Radionuclide devices
- Leksell GammaPlan 1567714Elekta Solutions AB · System, Radiation Therapy, Radionuclide1 recall4 reports
- Leksell Gamma Knife Icon 1016200Elekta Solutions AB · System, radiation therapy, radionuclide1 recall3 reports
- Leksell Gamma Knife Perfexion 715000Elekta Solutions AB · System, radiation therapy, radionuclide1 recall1 report
- Leksell Gamma Knife Esprit 1110200Elekta Solutions AB · System, Radiation Therapy, Radionuclide1 recall0 reports
- Leksell GammaPlan 1529980Elekta Instrument AB · System, radiation therapy, radionuclide1 recall0 reports
- GammaPod™ Treatment Planning System Model AXcision Medical Systems, LLC · System, Radiation Therapy, Radionuclide1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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