FDA Device recall Z-2006-2026
Brand Name: Leksell Vantage Arc System REF: 1053958
- FDA Device
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Brand Name: Leksell Vantage Arc System REF: 1053958 by Elekta, citing locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2006-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-19 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Elekta |
| Distribution | 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 |
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.
Identifiers
| code_info | Lot Code: Arc System: UDI:07340048304856 Parts of Arc System: Left Z-Slide: Serial Numbers :UDI: 07340048304818 00001 0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2026%22
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