Recall Z-2473-2020— Elekta, Inc.

Name: FDA recall Z-2473-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-18

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2019-12-18, terminated 2021-06-15. It names one FDA 510(k) clearance: K192482. Product: Elekta Unity, Image-Guided Radiation Therapy System. Reason: There have been reports of excessive heating in the MRL Gradient Connection Module..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-18
Terminated: 2021-06-15
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K192482 — Elekta UnityElekta Limited·cleared 2019-12-05

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

Reason for recall

There have been reports of excessive heating in the MRL Gradient Connection Module.

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