ELEKTA LIMITED Versa HD — Class II medical device recall Z-0445-2024
Ongoing recall by Elekta, Inc., reported 2023-12-13. Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential
| Recall number | Z-0445-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2023-10-25 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Quantity | 451 units |
| UPC / GTIN / UDI-DI | 05060191071529, 05060191071574 |
| Serial numbers | 109003, 109004, 109005, 109007, 152777, 152843, 152912, 152917, 152944, 152948, 152951, 152954, 152960, 152995, 153003, 153008, 153023, 153025, 153037, 153044, 153055, 153095, 153096, 153097, 153104 and 426 more |
| Model numbers | 2121, 2131 |
Product
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Reason for recall
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension.
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-0445-2024. 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.