Leksell GammaPlan 1567714Recalls & reported problems
Elekta Solutions AB · Leksell GammaPlan 11.4 · Class 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
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07340201502136), received between Oct 30, 2025 and Dec 23, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).
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 Method3
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Unintended Radiation Exposure3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED THAT AN OBSOLETE STEREOTACTIC REFERENCE USED FOR TREATMENT.
Patient problems: Unintended Radiation Exposure
MAUDE report 23877055 ↗MalfunctionNov 27, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE CUSTOMER REPORTED AN ISSUE WITH THE CBCT SYSTEM DURING CO-REGISTRATION WHERE SOMETIMES THE IMAGES DO NOT APPEAR AFTER ACQUISITION, OR ARE GETTING ASSIGNED TO THE WRONG PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23664380 ↗InjuryOct 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED A MISMATCH OF MR VS CBCT #2.
Patient problems: Unintended Radiation Exposure
MAUDE report 23423452 ↗InjuryOct 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE CUSTOMER REPORTED A MISMATCH OF MR VS CBCT #1.
Patient problems: Unintended Radiation Exposure
MAUDE report 23422727 ↗
Other System, Radiation Therapy, Radionuclide devices
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- 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
- Leksell GammaPlan 1529980Elekta Instrument AB · 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 · 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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