Jun

2016

Cl II elekta iGUIDE System

Company: Elekta Inc.
Date of Enforcement Report 6/1/2016
Class lI:

PRODUCT

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.
Recall Number Z-1705-2016

REASON
If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data..

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta, GA on 5/12/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
20

DISTRIBUTION
IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

___________________________________

About the author

Amy Sellers

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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Cl II elekta iGUIDE System

Amy Sellers

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