Leksell GammaPlan 1529980Recalls & reported problems
Elekta Instrument AB · LGP 11.1 · Class 2
All models of Leksell GammaPlan (2)
Data updated Oct 16, 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
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Dec 12, 2025Open, Classified
Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.
Z-1339-2026 · Root cause: Use error · Recall details · FDA record ↗
Other System, radiation therapy, radionuclide devices
- GammaPod™ Model AXcision Medical Systems, LLC · System, Radiation Therapy, Radionuclide2 recalls0 reports
- 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
- 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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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