FDA Device recall Z-1675-2023
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil
- FDA Device
- Class II
- ongoing
- Published 2023-06-14
On 2023-06-14 the FDA classified a Class II recall of Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil by Elekta, citing there is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1675-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-06 |
| Published | 2023-06-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Elekta |
| Distribution | US |
Product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Reason
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Identifiers
| code_info | UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-…UDI GTIN 05060191071598, serial numbers: 14117-007/600034, 10632-010/600036, 10817-011/600010, 10905-008/600037, 11198-010/600047, 11198-011/600048, 11830-010/600064, 11888-004/600072, 12108-007/600019, 13371-002/600021, 13553-006/600003, 30003193-003/600074, 13120-017/600073, 11328-019/600059, 14232-001/600095, 12269-004/600100, 11008-003/600104, 13212-007/600106 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1675-2023%22
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