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ELEKTA SOLUTIONS AB devices, product family

by ELEKTA SOLUTIONS ABand 1 other manufacturer record 12 variants Basic UDI-DI 073402015BUDI000000019PS

Shared by every variant

Manufacturer
ELEKTA SOLUTIONS AB(7)Elekta Solutions AB(5)
Several manufacturer records share this Basic UDI-DI.
Basic UDI-DI
073402015BUDI000000019PS
Risk class
Class IClass II (varies)
Legislation
MDR
EMDN category
STEREOTACTIC NEUROSURGERY SYSTEMS
Market status
12 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 073402015BUDI000000019PS.

Recalls

4 recalls · 2 ongoing · FDA

  • Z-2006-2026 Class II · ongoing · 19 Mar 2026
    Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
  • Z-0433-2026 Class II · ongoing · 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
  • Z-2442-2020 Class II · terminated · 10 Jun 2020
    The locking mechanism at the interface of the Instrument Carrier and the Leksell Vantage Arc may not function properly.
  • Z-1826-2020 Class II · terminated · 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.

Recalls matched to the 12 devices listed on this page; other pages of the family can carry others.

Variants

12 devices · page 1 of 1

Variants of ELEKTA SOLUTIONS AB devices, Basic UDI-DI 073402015BUDI000000019PS
UDI-DISize and differences
Leksell Vantage Stereotactic System 1040014
Elekta Solutions AB
1040014 / 104001407340201501399
Single use: no
On the market
Leksell Vantage Stereotactic System 1040026
Elekta Solutions AB
1040027 / 104002607340201501368
Single use: yes
On the market
Leksell Vantage Stereotactic System 1040036
Elekta Solutions AB
1040036 / 104003607340201501849
Single use: no
On the market
Leksell Vantage Stereotactic System 1040110
Elekta Solutions AB
1040110 / 104011007340201501795
Single use: no
On the market
Leksell Vantage Stereotactic System 1040114
Elekta Solutions AB
1040114 / 104011407340201502259
Single use: no
On the market
Leksell Vantage X-Ray Fiducial Box
ELEKTA SOLUTIONS AB
1136431 / Leksell Vantage Stereotactic System (Class I)07340201503676 —On the market
Leksell Vantage X-Ray Table Fixation
ELEKTA SOLUTIONS AB
1136512 / Leksell Vantage Stereotactic System (Class I)07340201503751 —On the market
Leksell Vantage X-Ray Universal Fixation
ELEKTA SOLUTIONS AB
1136528 / Leksell Vantage Stereotactic System (Class I)07340201503775 —On the market
Vantage Adapter for Mayfield
ELEKTA SOLUTIONS AB
1578097 / Leksell Vantage Stereotactic System (Class I)07340201503928 —On the market
Vantage Radiolucent Adapter for Doro
ELEKTA SOLUTIONS AB
1136545 / Leksell Vantage Stereotactic System (Class I)07340201503690 —On the market
Vantage Radiolucent Adapter for Imris
ELEKTA SOLUTIONS AB
1136561 / Leksell Vantage Stereotactic System (Class I)07340201503706 —On the market
Vantage Radiolucent Adapter for Mayfield
ELEKTA SOLUTIONS AB
1578094 / Leksell Vantage Stereotactic System (Class I)07340201503935 —On the market