Brand Name: Leksell Vantage Arc System REF: 1053958 — Class II medical device recall Z-2006-2026
Ongoing recall by Elekta, Inc., reported 2026-05-06, distributed in AR, AZ, CA, CO, DC, FL, GA, ID…. Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during proc
| Recall number | Z-2006-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2026-03-19 |
| Classified | 2026-04-29 |
| Reported by FDA | 2026-05-06 |
| Distributed | 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 |
| Countries outside the US | AT, AU, BE, CH, CN, CO, CR, CZ, DE, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, KW, LT, MA, MX, NL, NO, NZ, PA, PK, PL, PT, SA, SE, SG, SI, TR, TW, ZA |
| UPC / GTIN / UDI-DI | 07340048304801, 07340048304818, 07340048304856 |
| Serial numbers | 00001, 00625, 00675, 07340048304818 |
| Model numbers | 1053958 |
Product
Brand Name: Leksell Vantage Arc System REF: 1053958
Reason for recall
Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2006-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.