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U.S. Department of Health and Human Services

Class 2 Device Recall iGUIDE Software 2.2

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  Class 2 Device Recall iGUIDE Software 2.2 see related information
Date Initiated by Firm June 19, 2017
Create Date August 10, 2017
Recall Status1 Terminated 3 on November 05, 2019
Recall Number Z-3017-2017
Recall Event ID 77590
510(K)Number K143485  
Product Classification Accelerator, linear, medical - Product Code IYE
Product iGUIDE Software 2.2

Product Usage:
Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
Code Information Scope; iGUIDE 2.2.0, iGUIDE 2.2.1
Recalling Firm/
Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
Incorrect PEC values.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action Elekta sent an Urgent Important Field Safety Notice 618-01-303-026 letter dated June 2017 to all affected customers. The letter identified the affected product, problem, the potential clinical impact and actions to be taken.. It also provides a workaround to avoid the issue.
Quantity in Commerce 110 units
Distribution Worldwide Distribution in the states of AK, CT, GA, KY, LA, MA, MD, MN, NC, NM, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and countries of Hawaii Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Netherlands, New Zealand, Poland, Slovenia, Spain, Sweden, Switzerland, United Kingdom, & Vietnam.
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