CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report

Leksell Vantage Arc System recalled by Elekta

Elekta is recalling Leksell Vantage Arc System, distributed in 28 states. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled768 (364Left/364Right)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2006-2026
FDA event ID: 98612
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 19 Mar 2026
FDA classified: 29 Apr 2026
Reported: 6 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

19 Mar 2026	Recall initiated by company
29 Apr 2026	Classified by FDA	+41 days
6 May 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Leksell Vantage Arc System REF: 1053958

Where it was distributed

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

Arkansas Arizona California Colorado District of Columbia Florida Georgia Illinois Kansas Massachusetts Maryland Missouri Montana North Carolina Nebraska New Hampshire New Jersey New Mexico Nevada New York

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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