Leksell Gamma Knife Perfexion 715000Recalls & reported problems
Elekta Solutions AB · LEKSELL GAMMA KNIFE PERFEXION · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07340048303019), received between Oct 21, 2019 and Oct 21, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (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 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
- Compatibility Problem1
- Device Displays Incorrect Message1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 21, 2019Device Displays Incorrect Message; Compatibility Problem; Compatibility Problem
MR FIDUCIAL BOX USE ERROR.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9213183 ↗
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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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