Leksell Stereotactic System Neurosurgical InstrumentsRecalls & reported problems across all models
Elekta Instrument AB · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Leksell Stereotactic System Neurosurgical Instruments model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 12 models of Leksell Stereotactic System Neurosurgical Instruments by Elekta Instrument AB in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 23, 2024 and Aug 23, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (1 report).
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 Neurosurgical Instruments 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, 2023Class IIOpen, Classified
The incorrect IFU was distributed with the devices.
Z-1309-2023 · Root cause: Labeling Change Control · names 11 of these models · Recall details · FDA record ↗
Most reported Leksell Stereotactic System Neurosurgical Instruments problems
Device problems
- Defective Component1
Patient problems
- Insufficient Information1
Leksell Stereotactic System Neurosurgical Instruments models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Leksell Stereotactic System Neurosurgical Instruments A2800-15Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 907801Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2200-01Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2600-01Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments A2800-26Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-01Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 60377-02Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50376-01Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 50398-01Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 14001050Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 307165Neurological stereotaxic Instrument1 recall0 reports
- Leksell Stereotactic System Neurosurgical Instruments 911933Neurological stereotaxic Instrument1 report
Recent Leksell Stereotactic System Neurosurgical Instruments adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THEY SUSPECTED BIOPSY NEEDLES TO BE CONTAMINATED.
Patient problems: Insufficient Information
MAUDE report 20046547 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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