25
Jun
2014

Cl II Elekta iGUIDE System Product Usage

0

Company:Elekta, Inc.
Date of Enforcement Report:6/25/2014
Class lI:

PRODUCT

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. Recall Number Z-1807-2014

REASON
A bug in the software prevents the iGUIDE software from logging off.

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 5/29/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
224

DISTRIBUTION
Nationwide and Internationally

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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