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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 Systemsee related information
Date Initiated by FirmMay 29, 2014
Date PostedJune 17, 2014
Recall Status1 Terminated 3 on September 29, 2017
Recall NumberZ-1807-2014
Recall Event ID 68430
510(K)NumberK072079 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductiGUIDE 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.
Code Information Software Versions 2.0.0, 2.0.1 and 2.0.2
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall		A bug in the software prevents the iGUIDE software from logging off.
FDA Determined
Cause 2		Software design
ActionElekta sent an Important Field Safety Notice 618 01 303 024 dated May 29, 2014 to affected customers. The letter identified the affected product, problem, potential clinical impact and actions to be taken. It also gives a recommendation how the risk can be mitigated - Users should only use the iGUIDE software when the key is in the on position and the Position Guard is active. Users are advised to restart the workstation if any error occurs to ensure the software is running properly. The notice also advises the customer that a patch will be released that corrects the behavior of the iGUIDE software. This solution will be implemented on all affected products when available. For questions contact your local Elekta office.
Quantity in Commerce224
DistributionWorldwide Distribution - USA (nationwide) in the states of AZ, CA, CT, HI, IL, IA, KY, MD, MA, MI, MO, NH, NJ, NC, ND, OH, OK, OR, PA, TX, VA, WA, WI, and the countries of Algeria, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Netherlands, New Zealand, Peru, Poland, Russia, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom and 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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