Leksell GammaPlan 1551287Recalls & reported problems
Elekta Instrument AB · Leksell GammaPlan · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340048311878), 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).
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.
Reports received per month
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-1340-2026 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, 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 ↗
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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 · each report above links to its original FDA record
- 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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