Elekta, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1675-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.

Product Classification:

Class II

Date Initiated: April 6, 2023

Date Posted: June 14, 2023

Recall Number: Z-1675-2023

Event ID: 92053

Reason for Recall:

There is a low possibility that an electrical connector in the MR gradient coil will overheat on Elekta Unity systems.

Status: Ongoing

Product Quantity: 18 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated