Jun

2014

Elekta MOSAIQ Cl II

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

PRODUCT

MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. Z-1800-2014.

REASON
When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen..

RECALLING FIRM/MANUFACTURER
Elekta Inc., Atlanta GA. on 4/23/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
723

DISTRIBUTION
Nationwide and Internationally

___________________________________

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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Elekta MOSAIQ Cl II

Amy Sellers

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