Device product
Brand Name: Leksell Vantage Arc System REF: 1053958
Z-2006-2026
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 98612
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 768 (364Left/364Right)
- Official record key
device-enforcement:Z-2006-2026
Official wording
Reason: Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
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
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
Derived failure modes
-
Unknown
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.