FDA DevicesClass II
Brand Name: Leksell Vantage Arc System REF: 1053958
Published: May 6, 2026Recall ID: Z-2006-2026Category: devicesCountry: US
Reason for Recall / Hazard
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Product Description & Identification
Brand Name: Leksell Vantage Arc System REF: 1053958
Affected Products
Brand Name: Leksell Vantage Arc System REF: 1053958
Additional Source Details
| Field | Value |
|---|---|
| City | Atlanta |
| State | GA |
| Event id | 98612 |
| Address 1 | 400 Perimeter Center Ter NE Ste 50 |
| 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 |
| Postal code | 30346-1227 |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 768 (364Left/364Right) |
| Reason for recall | Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmElekta, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionUS: 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