iGUIDE 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.
FDA Recall Z-1807-2014 · Posted 2014-06-17
Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-05-29
Date Terminated2017-09-29
Product Quantity224
Reason for Recall
A bug in the software prevents the iGUIDE software from logging off.
Firm Action
Elekta 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.
Root Cause
Software design
Distribution Pattern
Worldwide 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.