Leksell Gamma Knife Icon 1016200Recalls & reported problems
Elekta Solutions AB · LEKSELL GAMMA KNIFE ICON · Class 2
Data updated Oct 18, 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340048305587), received between Mar 8, 2017 and Sep 8, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Misassembled” (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 18, 2026.
Recalls naming this device
- Feb 18, 2026Class IIOpen, Classified
Due to adapter not being properly aligned or locked in place.
Z-1581-2026 · Root cause: Use error · Recall details · FDA record ↗
Most reported problems
Device problems
- Misassembled3
- Disconnection1
Patient problems
- No Patient Involvement3
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2017Misassembled; Disconnection; Misassembled
DURING UNLOADING OF SOURCES BY ELEKTA ENGINEERS, SIX SLEEVES CAME LOOSE AND LATER ON WHEN THE EMERGENCY PORT HAD BEEN OPENED, AN ADDITIONAL SIX SLEEVES WERE ALSO CONSIDERED TO BE LOOSE.
Patient problems: No Information; No Patient Involvement
MAUDE report 6851232 ↗MalfunctionMar 30, 2017Misassembled; Misassembled
WHEN REPLACING A FAULTY GANTRY MODULE ON A NEW INSTALLATION, IT WAS DISCOVERED THAT SETTINGS CONTROLLING THE KV GENERATOR USING LANTRONIX/MATCHPORT WERE LOST AS THEY ARE STORED LOCALLY IN THE GANTRY MODULE.
Patient problems: No Patient Involvement
MAUDE report 6445391 ↗MalfunctionMar 8, 2017Misassembled; Misassembled
DURING INSTALLATION OF LEKSELL GAMMA KNIFE ICON IT WAS IDENTIFIED BY AN ELEKTA INSTALLATION ENGINEER THAT SOME OF THE INTERNAL WIRING WAS NOT CONNECTED CORRECTLY. THE DEVICE IS NOT IN CLINICAL USE.
Patient problems: No Patient Involvement
MAUDE report 6386755 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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