Recall Z-1705-2016— Elekta, Inc.

Name: FDA recall Z-1705-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-12

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2016-05-12, terminated 2021-07-16. It names one FDA 510(k) clearance: K072079. Product: iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.. Reason: If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data..

Recalling firm: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-05-12
Terminated: 2021-07-16
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, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

Reason for recall

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

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