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Leksell Stereotactic System 1040322

by Elekta Solutions AB

Ref 1040322Model Leksell Stereotactic System (Class I)

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number073402015BUDI000000021PD Basic UDI-DI 07340201502433UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07340201502433 UDI-DI Date17 Oct 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · 3 ongoing · FDA

    • Ongoing Z-0227-2025 FDA Class I initiated 25 Sep 2024

    Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.

    • Ongoing Z-1397-2024 FDA Class I initiated 15 Mar 2024

    Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.

    • Ongoing Z-1309-2023 FDA Class II initiated 1 Mar 2023

    The incorrect IFU was distributed with the devices.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ear Plug EUDAMED
Leksell Stereotactic System GUDID
Generic Name
Neurological stereotactic surgery system
Model / Reference
1040322, Leksell Stereotactic System (Class I)
Primary DI / UDI-DI
07340201502433
Basic UDI-DI
073402015BUDI000000021PD
510(k) Number
FDA Product Code
HAW
EMDN Code
Z12100601 Stereotactic neurosurgery systems
GMDN Term
Neurological stereotactic surgery system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.4560
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K152558)

Show all (12)

Other devices from Elekta Solutions AB

See all devices from Elekta Solutions AB →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No