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Leksell Vantage Stereotactic System 1128643

by Elekta Solutions AB

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07340201503577 UDI-DI Date8 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-2006-2026 FDA Class II initiated 19 Mar 2026

    Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.

    • Ongoing Z-0433-2026 FDA Class II initiated 30 Sep 2025

    Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound

    • Terminated Z-1826-2020 FDA Class II initiated 30 Mar 2020

    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.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Leksell Vantage Stereotactic System
Generic Name
Neurological stereotactic surgery system
Model / Reference
1128643
Primary DI / UDI-DI
07340201503577
510(k) Number
FDA Product Code
HAW
GMDN Term
Neurological stereotactic surgery system
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K190887)

Show all (12)

Other devices from Elekta Solutions AB

See all devices from Elekta Solutions AB →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No