Elekta, Inc.: Neurological Stereotaxic Instrument
Recall Summary Elekta, Inc. is recalling the Leksell Vantage Arc System, a neurological surgical instrument used in procedures, because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifts during surgery. The device has been distributed across multiple U.S. states and numerous countries worldwide. This is classified as a Class II recall.
- Recalling firm
- Elekta, Inc.
- Product
- Brand Name: Leksell Vantage Arc System REF: 1053958
- Reason
- Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-19
- Status
- Open, Classified
- Areas affected
- AZ, AR, CA, CO, FL, GA, ID, IL, KS, MD, MA, MO, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0ba78e83-a5a6-4ab1-be06-03df93f1f798