Elekta Unity Image-Guided Radiation Therapy System containing an MR… — Class II medical device recall Z-1675-2023
Ongoing recall by Elekta, Inc., reported 2023-06-14, distributed nationwide. There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity
| Recall number | Z-1675-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 18 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05060191071598 |
| Serial numbers | 10632-010/600036, 10817-011/600010, 10905-008/600037, 11008-003/600104, 11198-010/600047, 11198-011/600048, 11328-019/600059, 11830-010/600064, 11888-004/600072, 12108-007/600019, 12269-004/600100, 13120-017/600073, 13212-007/600106, 13371-002/600021, 13553-006/600003, 14117-007/600034, 14232-001/600095, 30003193-003/600074 |
Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Reason for recall
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
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-1675-2023. 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.