Leksell Stereotactic SystemRecalls & reported problems across all models
Elekta Instrument AB · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Leksell Stereotactic System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 1
- Injuries reported
- 2
- Recalls
- 1
We found 4 models of Leksell Stereotactic System by Elekta Instrument AB in the FDA's device registry (GUDID). Together they are named in 9 adverse event reports in the FDA's MAUDE database, received between Jul 25, 2018 and Jun 18, 2025 — classified as 1 death, 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).
1 FDA recall record name at least one of these models by its device 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. 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 Stereotactic System 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.
- Mar 1, 2023Open, Classified
The incorrect IFU was distributed with the devices.
Z-1309-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported Leksell Stereotactic System problems
Device problems
- Insufficient Device Problem Information3
- Adverse Event Without Identified Device or Use Problem2
- Use of Device Problem2
- Connection Problem1
- Defective Device1
- Device Handling Problem1
- Malposition of Device1
- Material Integrity Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- Burn(s)1
- Burn, Thermal1
- Intracranial Hemorrhage1
- No Consequences Or Impact To Patient1
- No Information1
Leksell Stereotactic System models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Leksell Stereotactic System 1002248Neurological stereotaxic Instrument1 recall3 reports
- Leksell Stereotactic System 1002136Neurological stereotaxic Instrument3 reports
- Leksell Stereotactic System 1000689Neurological stereotaxic Instrument1 death2 reports
- Leksell Stereotactic System 912877Neurological stereotaxic Instrument1 report
Recent Leksell Stereotactic System adverse event reports
The 9 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION PROVIDED BY FDA - REFERENCE NUMBER MW5150997. PATIENT UNDERGOING BILATERAL DBS ELECTRODE IMPLANT USING LEKSELL FRAME. ONE ELECTRODE WAS IMPLANTED, AND CT USED TO CHECK PLACEMENT. ERROR WAS GREATER THAN ACCEPTABLE OR EXPECTED. THE SPARE ARC/RING WAS STERILIZED, AND THE ELECTRODE WAS REIMPLANTED. ERROR WAS IMPROVED, BUT WAS NOT ACCEPTABLE AND NOT EXPLAINABLE BY HUMAN ERROR OR NATURAL DEVIATIONS. THE INCISION WAS CLOSED. INTENSIVE TROUBLESHOOTING WAS PERFORMED. MY PARTNER WAS CONSULTED AS WELL FOR ADDITIONAL PERSPECTIVES ON CAUSES. ADDITIONAL SCANNING, AND "PHANTOM" TARGETS THAT WERE NON-INVASIVE WERE TARGETED WITH THE ARC/RING. THE LEKSELL FIDUCIAL BOX WAS TESTED, WITH HIGH BUT NOT UNACCEPTABLE ERROR PER NAVIGATION SYSTEM. OPERATION WAS ABORTED DUE TO LACK OF FUNCTIONING EQUIPMENT; MORE THAN ONE POSSIBLE MALFUNCTIONING PIECE OF EQUIPMENT, WITH A NON-LINEAR ERROR THAT COULD NOT BE RESOLVED.
Patient problems: Insufficient Information
MAUDE report 22282535 ↗InjuryApr 25, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE G-FRAME SLIPPED DURING TREATMENT.
Patient problems: Insufficient Information
MAUDE report 21909181 ↗MalfunctionFeb 1, 2024
PATIENT UNDERGOING BILATERAL DBS ELECTRODE IMPLANT USING LEKSELL FRAME. ONE ELECTRODE WAS IMPLANTED, AND CT USED TO CHECK PLACEMENT. ERROR WAS GREATER THAN ACCEPTABLE OR EXPECTED. THE SPARE ARC/RING WAS STERILIZED, AND THE ELECTRODE WAS REIMPLANTED. ERROR WAS IMPROVED, BUT WAS NOT ACCEPTABLE AND NOT EXPLAINABLE BY HUMAN ERROR OR NATURAL DEVIATIONS. THE INCISION WAS CLOSED. INTENSIVE TROUBLESHOOTING WAS PERFORMED. MY PARTNER WAS CONSULTED AS WELL FOR ADDITIONAL PERSPECTIVES ON CAUSES. ADDITIONAL SCANNING, AND "PHANTOM" TARGETS THAT WERE NON-INVASIVE WERE TARGETED WITH THE ARC/RING. THE LEKSELL FIDUCIAL BOX WAS TESTED, WITH HIGH BUT NOT UNACCEPTABLE ERROR PER NAVIGATION SYSTEM. OPERATION WAS ABORTED DUE TO LACK OF FUNCTIONING EQUIPMENT; MORE THAN ONE POSSIBLE MALFUNCTIONING PIECE OF EQUIPMENT, WITH A NON-LINEAR ERROR THAT COULD NOT BE RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18630647 ↗DeathJan 12, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE CUSTOMER REPORTED BLEEDING OCCURING DURING DBS (DEEP BRAIN STIMULATION) SURGERY WHICH LED TO THE PATIENT BEING PLACED IN INTENSIVE CARE POST-OPERATIVELY AND LATER DIED.
Patient problems: Intracranial Hemorrhage
MAUDE report 16145661 ↗MalfunctionApr 1, 2021Connection Problem; Material Integrity Problem; Material Integrity Problem
THE CUSTOMER REPORTED THAT THE FIXATION SCREWS DOES NOT FEEL RIGID WHEN MOUNTED IN THE DISPOSABLE INSERTS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11601233 ↗InjuryApr 7, 2020Use of Device Problem; Malposition of Device; Use of Device Problem
THE CUSTOMER REPORTED THAT THE HEADFRAME SHIFTED DURING TREATMENT.
Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem
MAUDE report 9932583 ↗MalfunctionNov 15, 2019Use of Device Problem; Use of Device Problem; Defective Device
THE CUSTOMER REPORTED A LEKSELL SYSTEM INACCURACY.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9326679 ↗MalfunctionMar 15, 2019Product Quality Problem; No Apparent Adverse Event; No Apparent Adverse Event
THE CUSTOMER REPORTED A DEVIATION ON THE LEFT SIDE OF THE ELEKTA G-FRAME.
Patient problems: No Information
MAUDE report 8424032 ↗MalfunctionJul 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT DURING THE MR SCAN WHILST USING THE FRAME PATIENTS HAVE EXPERIENCED BURN MARKS. BASED ON THE AVAILABLE INFORMATION ACTUAL INJURY HAS OCCURRED.
Patient problems: Burn(s); Burn, Thermal
MAUDE report 7718229 ↗
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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