Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma… — Class II medical device recall Z-1581-2026
Ongoing recall by Elekta, Inc., reported 2026-03-25, distributed nationwide. Due to adapter not being properly aligned or locked in place.
| Recall number | Z-1581-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-19 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BR, CA, CL, CN, CO, CZ, DE, DO, DZ, EC, EG, ES, FR, GB, GR, HK, HR, ID, IN, IQ, IR, IT, JO, JP, KR, KW, LT, MA, MX, MY, NL, NO, PE, PH, PK, PL, PT, RO, RS, SA, SE, SG, SV, TH, TR, TW, VN, ZA |
| Quantity | 352 |
| UPC / GTIN / UDI-DI | 07340048303019, 07340048305587, 07340201501139 |
| Serial numbers | 07340048305587, ESPRIT/10076-GK002/8045LGK, ESPRIT/10158-LGK/8163LGK, ESPRIT/10255-013/8165LGK, ESPRIT/10349-007/8161LGK, ESPRIT/10375-LGK002/8126LGK, ESPRIT/10379-004/8137LGK, ESPRIT/10383-LGK012/6100LGK, ESPRIT/10444-001/8185LGK, ESPRIT/10459-LGK002/8152LGK, ESPRIT/10523-LGK001/8187LGK, ESPRIT/10542-015/6238LGK, ESPRIT/10567-048/8142LGK, ESPRIT/10567-050/8052LGK, ESPRIT/10567-053/6232LGK, ESPRIT/10567-054/8168LGK, ESPRIT/10587-LGK001/8181LGK, ESPRIT/10622-014/8140LGK, ESPRIT/10636-007/8062LGK, ESPRIT/10643-007/8191LGK, ESPRIT/10673-031/8141LGK, ESPRIT/10684-002/6090LGK, ESPRIT/10711-LGK001/8195LGK, ESPRIT/10714-013/8159, ESPRIT/10779-08/8024LGK and 326 more |
Product
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Reason for recall
Due to adapter not being properly aligned or locked in place.
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-1581-2026. 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.