Z-2006-2026Class II

Brand Name: Leksell Vantage Arc System REF: 1053958

Name: Z-2006-2026 Brand Name: Leksell Vantage Arc System REF: 1053958
Creator: Elekta, Inc.
Published: 2026-03-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2026-03-19 / Open, Classified / root cause: design

FDA source

Elekta, Inc. began a recall of Brand Name: Leksell Vantage Arc System REF: 1053958 on 2026-03-19. FDA classified it as Class II and gives the reason as "Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2006-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-04-29
Recalling firm: Elekta Limited
Product: Brand Name: Leksell Vantage Arc System REF: 1053958
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Root cause tag: design
FDA root cause: Device Design
Action: On March 19, 2026 Elekta issued a "Urgent: Medical Device Recall" notification via e-mail. Elekta asked consignees 1. Before each operation, products should be cleaned, sterilized (unless specified otherwise), and checked for proper functionality. 2. Make sure to examine all scales and angles to make sure that they are correctly set and securely fixed before proceeding. 3. Make sure to obtain a second person in the OR room to read the coordinate settings so as to ensure they are correct and check they are securely locked. 4. Before you continue, check that all parts are assembled correctly, firmly attached, and locked in place. 5. Inspect the equipment for visible signs of damage before clinical use. Do not use damaged equipment for any purpose. If you suspect that any part is damaged, contact your Elekta representative immediately. 6. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 7. Advise the appropriate personnel working with this product, on the content of this letter. If the product has been transferred to another facility, please provide them with a copy of this communication.
Quantity in commerce: 768 (364Left/364Right)
Distribution: US: AR AZ CA CO DC FL GA ID IL KS MA MD ME MO MT NC NE NH NJ NM NV NY OH OK PA SC TX UT VA WA WI WV OUS: Algeria Australia Austria Azerbaijan Belgium China Colombia Costa Rica Croatia Czech Republic Egypt Estonia Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Korea, Republic of Kuwait Lithuania Mexico Morocco Netherlands New Zealand Norway Pakistan Panama Poland Portugal Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
Product codes and lots: Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 00625 Right Z-Slide: UDI: 07340048304801/ Serial Numbers: 00001 00675

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2006-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2006-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code HAW

K190887Class IILeksell Vantage Stereotactic SystemElekta Instrument AB / cleared 2019-08-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)