PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: November 7, 2012 Initiated: September 18, 2012 #Z-0169-2013

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.

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.

Details

Recalling Firm
Elekta, Inc.
Units Affected
300
Distribution
Worldwide distribution: USA (nationwide) and country of Canada.
Location
Norcross, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Elekta, Inc.. Units affected: 300.
Why was this product recalled?
A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 7, 2012. Severity: Moderate. Recall number: Z-0169-2013.