Home / Recalls / Elekta, Inc. / Z-2006-2026

Z-2006-2026 Class II Ongoing

Recalled by Elekta, Inc. — Atlanta, GA

FDA device recall Z-2006-2026 was initiated by Elekta, Inc. on March 19, 2026 and is designated Class II. Reason for recall: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. The recall status is ongoing. Affected quantity: 768 (364Left/364Right).

Recall Details

Product Type: Devices
Report Date: May 6, 2026
Initiation Date: March 19, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 768 (364Left/364Right)

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.

Distribution Pattern

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

Code Information

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

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