Recall Z-1675-2023— Elekta, Inc.

Name: FDA recall Z-1675-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-06

Class II · Ongoing

Class II FDA medical device recall by Elekta, Inc., initiated 2023-04-06. It names one FDA 510(k) clearance: K212114. 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..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-06
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K212114 — Elekta UnityElekta Solutions AB·cleared 2021-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.