Elekta Medical Linear Accelerator — Class II medical device recall Z-1665-2023
Ongoing recall by Elekta, Inc., reported 2023-06-07, distributed in AR, IN, LA, OK, TN, VA, WA. A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
| Recall number | Z-1665-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2023-05-05 |
| Classified | 2023-05-30 |
| Reported by FDA | 2023-06-07 |
| Distributed | AR, IN, LA, OK, TN, VA, WA |
| Countries outside the US | BE, CA, CL, CN, DE, ES, FR, IN, IQ, IT, JO, MA, MX, PL |
| Quantity | 46 units |
| UPC / GTIN / UDI-DI | 05060191071505, 05060191071512, 05060191071529, 05060191071543, 05060191071550, 05060191071574 |
| Serial numbers | 152223, 152483, 153681, 156073, 156724, 156941, 156989, 156998 |
| Model numbers | 95510354H-01 |
Product
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
Reason for recall
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
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-1665-2023. 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.