Leksell Vantage Stereotactic System 1055007Recalls & reported problems
Elekta Instrument AB · ARC CARRIER · Class 2
All models of Leksell Vantage Stereotactic System (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 07340048304887), received between Mar 24, 2020 and Mar 24, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
1 FDA recall record name this device's identifier.
1 other recall 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.
Recalls naming this device
- Mar 30, 2020Class IITerminated
A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
Z-1826-2020 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING AN INTERNAL INSPECTION OF TWO VANTAGE ARC SYSTEMS, IT WAS FOUND THAT THE ARC CARRIER WAS UNABLE TO LOCK SECURELY.
Patient problems: No Patient Involvement
MAUDE report 9872404 ↗
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
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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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