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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