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U.S. Department of Health and Human Services

Class 2 Device Recall iGUIDE System

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  Class 2 Device Recall iGUIDE System see related information
Date Initiated by Firm May 12, 2016
Date Posted May 23, 2016
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-1705-2016
Recall Event ID 74087
510(K)Number K072079  
Product Classification Accelerator, linear, medical - Product Code IYE
Product iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Code Information Software iGUIDE 2.1 and 2.2
Recalling Firm/
Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
Manufacturer 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.
FDA Determined
Cause 2
Software design
Action Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution  Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.
Quantity in Commerce 20
Distribution IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA