Leksell Stereotactic System 1002136Recalls & reported problems
Elekta Instrument AB · LEKSELL COORDINATE FRAME G · Class 2
All models of Leksell Stereotactic System (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340048305075), received between Mar 15, 2019 and Apr 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K152558); they may or may not involve this specific model.
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
Most reported problems
Device problems
- Device Handling Problem1
- Malposition of Device1
- No Apparent Adverse Event1
- Product Quality Problem1
- Use of Device Problem1
Patient problems
- Insufficient Information1
- No Information1
- No Known Impact Or Consequence To Patient1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K152558. One submission often covers many models, so check the product and lot details in each record.
- Z-0227-2025 · Sep 25, 2024 · Open, ClassifiedElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for
- Z-1397-2024 · Mar 15, 2024 · Open, ClassifiedElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Ki
- Z-1309-2023 · Mar 1, 2023 · Open, ClassifiedInstructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part
Other Neurological stereotaxic Instrument devices
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument4 deaths4,668 reports
- Stealthstation® S7™ 9733856Medtronic Navigation, Inc. · Neurological stereotaxic Instrument6 deaths3,908 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death1,896 reports
- StealthStation S8 9735669Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1,831 reports
- StealthStation S8 Platform 9735665Medtronic Navigation, Inc. · Neurological stereotaxic Instrument2 deaths1,542 reports
- Fusion™ ENT Image Guidance System 9733560XOMMedtronic Navigation, Inc. · Neurological stereotaxic Instrument1,316 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument8 deaths984 reports
- Stealthstation® S7™ 9733858Medtronic Navigation, Inc. · Neurological stereotaxic Instrument1 death695 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
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page