Recall archive / FDA device enforcement
Brand Name: Leksell Vantage Arc System REF: 1053958 — FDA record Z-2006-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Elekta, Inc.
- Quantity
- 768 (364Left/364Right)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2006-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 6, 2026
- Recall initiation date
- Mar 19, 2026
- Center classification date
- Apr 29, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.