Z-1675-2023 Class II Ongoing
FDA device recall Z-1675-2023 was initiated by Elekta, Inc. on April 6, 2023 and is designated Class II. Reason for recall: There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems. The recall status is ongoing. Affected quantity: 18 devices.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 devices
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of FL, IA, NJ, NY, OK, PA, TN, WI, MI, LA, KS, NM and TX.
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