Recall Z-2006-2026— Elekta, Inc.

Name: FDA recall Z-2006-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2026-03-19. It names one FDA 510(k) clearance: K190887. Product: Brand Name: Leksell Vantage Arc System REF: 1053958. Reason: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-03-19
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K190887 — Leksell Vantage Stereotactic SystemElekta Instrument AB·cleared 2019-08-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: Leksell Vantage Arc System REF: 1053958

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.