United StatesThe Leksell Vantage Arc System REF: 1053958 (Arc System UDI: 07340048304856; Left Z‑Slide UDI: 07340048304818, serial numbers 00001–00625; Right Z‑Slide UDI: 07340048304801, serial numbers 00001–00675) is being recalled. Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What's being recalled
Brand Name: Leksell Vantage Arc System REF: 1053958
Recalling firm: Elekta, Inc., Atlanta, GA, United States.
How to identify it
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
The hazard
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)