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Leksell Vantage Arc System
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MEDICAL DEVICE RECALLMODERATE

Leksell Vantage Arc System

Elekta is recalling the Leksell Vantage Arc System due to a risk of coordinate shifting caused by faulty locking mechanisms.

What to do

Contact your Elekta representative or service technician to arrange for an inspection and repair of the locking mechanism.

Recalled
Listed
Updated
Recall No.
Z-2006-2026
Agency
FDA
Firm
Elekta, Inc.
Recall ID
98612
Status
ONGOING

Recall at a glance

Quantity recalled
768 (364Left/364Right)

Why it was recalled

The locking mechanisms on the Leksell Vantage Arc System may fail to secure properly, which can cause coordinate shifting during medical procedures. This recall affects the specific reference number listed.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Brand Name: Leksell Vantage Arc System REF: 1053958

UDI-DI
07340048304856, 07340048304818, 07340048304801

Where it was sold

Distributed in Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Idaho, Illinois, Kansas, Massachusetts, Maryland, Maine, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Elekta, Inc.

All recalls from Elekta, Inc.

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification