Recall Z-1807-2014— Elekta, Inc.

Name: FDA recall Z-1807-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-29

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2014-05-29, terminated 2017-09-29. It names one FDA 510(k) clearance: K072079. Product: iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.. Reason: A bug in the software prevents the iGUIDE software from logging off..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Terminated: 2017-09-29
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 Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Tracking System in a radiotherapy environment.

Reason for recall

A bug in the software prevents the iGUIDE software from logging off.

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