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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 2.2see related information
Date Initiated by FirmJune 19, 2017
Create DateAugust 10, 2017
Recall Status1 Terminated 3 on November 05, 2019
Recall NumberZ-3017-2017
Recall Event ID 77590
510(K)NumberK143485 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductiGUIDE 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/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactCustomer Service
770-670-2422
Manufacturer Reason
for Recall		Incorrect PEC values.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionElekta 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 Commerce110 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = IYE
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