Recall Z-2230-2019— Elekta, Inc.

Name: FDA recall Z-2230-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-19

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2019-06-19, terminated 2024-05-06. It names one FDA 510(k) clearance: K072079. Product: iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2. Reason: Potential for iGUIDE to incorrectly monitor the 3D position..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-19
Terminated: 2024-05-06
Firm location: Atlanta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K072079 — IGUIDE SYSTEMMedical Intelligence Medizintechnik-GmbH-An Elekta·cleared 2007-08-14

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

iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2

Reason for recall

Potential for iGUIDE to incorrectly monitor the 3D position.

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