Elekta, Inc.: Brand Name: Leksell Vantage Arc System REF: 1053958

Hazard

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

Details from the source

Reason for recall: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. 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 Quantity: 768 (364Left/364Right) Lot/code info: 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

UPC codes

07340048304856, 07340048304818, 07340048304801

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.