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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Product Detail

Product Description 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
Classification Class II
Code Info Version 2.00 to 2.41
Product Distributed Qty 300
Reason For Recall A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.

Event Detail

Event Id 63335
Product Type Devices
Status Ongoing
Recalling Firm Elekta, Inc.
City Norcross
State GA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and country of Canada.