Cl ll MOSAIQ electronic medical record system

Company:Elekta, Inc
Date of Enforcement Report 11/7/12
Class ll:

PRODUCT

MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images. Recall Number Z-0169-2013

REASON
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.

RECALLING FIRM/MANUFACTURER
Elekta, Inc., Norcross, GA on 9/18/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
300

DISTRIBUTION
Nationwide and Canada

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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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