Leksell GammaPlanRecalls & reported problems across all models
Elekta Instrument AB · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Leksell GammaPlan model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 2 models of Leksell GammaPlan by Elekta Instrument AB in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Feb 5, 2025 and Feb 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Leksell GammaPlan recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1340-2026 · Root cause: Use error · Recall details · FDA record ↗
- 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 ↗
Most reported Leksell GammaPlan problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
Leksell GammaPlan models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Leksell GammaPlan 1551287System, planning, radiation therapy treatment1 recall1 report
- Leksell GammaPlan 1529980System, radiation therapy, radionuclide1 recall0 reports
Recent Leksell GammaPlan adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER CONTACTED ELEKTA TO ASK WHETHER THE "SHOT COORDINATES" IN THE GK TREATMENT PLAN REPORT REPRESENT ABSOLUTE COUCH COORDINATES (IN THE MACHINE'S FRAME OF REFERENCE) OR IF THEY VARY DEPENDING ON WHICH SCAN IS USED AS THE STEREOTACTIC REFERENCE.
Patient problems: Insufficient Information
MAUDE report 21311042 ↗
Other Elekta Instrument AB products
All Elekta Instrument AB devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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