Leksell Vantage Stereotactic System 1051800Recalls & reported problems
Elekta Instrument AB · Leksell Vantage™ Head Frame · Class 2
All models of Leksell Vantage Stereotactic System (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07340048305167), received between Nov 20, 2019 and Jun 12, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Handling Problem” (5 reports).
2 other recalls cover devices cleared under the same FDA submission (K171123); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem5
- Insufficient Device Problem Information2
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME SLIPPED, NOTED PRIOR TO TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192869 ↗MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME HAD SLIPPED ON 4 DIFFERENT OCCASIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192868 ↗MalfunctionJun 12, 2025Device Handling Problem; Device Handling Problem
THE CUSTOMER REPORTED THAT THE VANTAGE FRAME SLIPPED, AND NOTED DURING POSITIONING OF THE PATIENT ON PPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22192867 ↗MalfunctionJun 16, 2023Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
THE CUSTOMER REPORTED THAT A PATIENT BECAME DISENGAGED FROM THE HEAD FRAME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17143049 ↗MalfunctionMar 31, 2023Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem
THE CUSTOMER REPORTED THAT THE PATIENTS HEAD WAS OUT OF POSITION DURING LGK TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16654840 ↗MalfunctionNov 20, 2019Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT THE PATIENT CAME OUT OF THE VANTAGE FRAME DURING A DBS (DEEP BRAIN STIMULATION) CASE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9346542 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171123. One submission often covers many models, so check the product and lot details in each record.
- Z-2442-2020 · Jun 10, 2020 · TerminatedLeksell Vantage Stereotactic System, UDI/GTIN 7340048304887
- Z-1826-2020 · Mar 30, 2020 · TerminatedLeksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
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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
- 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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