Brand Name: Leksell Vantage Arc System recall
Brand Name: Leksell Vantage Arc System REF: 1053958
Why was Brand Name: Leksell Vantage Arc System recalled?
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- Product
- Brand Name: Leksell Vantage Arc System REF: 1053958
- Recalling firm
- Elekta, Inc.
- Quantity
- 768 (364Left/364Right)
- 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 Saudi Arabia Singapore Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)