ELEKTA LIMITED Elekta Infinity — Class II medical device recall Z-0446-2024
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-0446-2024 |
|---|---|
| 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 | 291 units |
| UPC / GTIN / UDI-DI | 05060191071512, 05060191071543 |
| Serial numbers | 151044, 151839, 151942, 151958, 151959, 151961, 151995, 152019, 152031, 152103, 152115, 152158, 152163, 152175, 152192, 152200, 152207, 152210, 152211, 152222, 152223, 152257, 152303, 152364, 152370 and 266 more |
| Model numbers | 0511, 0521, 0531, 0541 |
Product
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; 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-0446-2024. 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.