Device product
Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.
Z-1675-2023
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 92053
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 devices
- Official record key
device-enforcement:Z-1675-2023
Official wording
Reason: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.
Code information: 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
Distribution pattern: US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
Derived failure modes
-
Unknown
There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.