Elekta Medical Linear Accelerator — Class II medical device recall Z-0115-2022
Terminated recall by ELEKTA SOLUTIONS AB, reported 2021-10-20, distributed in NC, ND. There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the mach
| Recall number | Z-0115-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ELEKTA SOLUTIONS AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-09-28 |
| Classified | 2021-10-14 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2024-06-14 |
| Distributed | NC, ND |
| Quantity | 2 in |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05060191071543, 05060191071574, 05060191071604 |
| Serial numbers | 156477, 156645, 156646, 156648, 441009 |
| Model numbers | 1552091, 1552093, 1555143 |
Product
Elekta Medical Linear Accelerator (EMLA): Elekta Harmony Pro, REF 1555143; Elekta Infinity, REF 1552091, and Elekta Versa HD, REF 1552093.
Reason for recall
There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter.
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-0115-2022. 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.