Recall Z-0169-2013— Elekta, Inc.

Name: FDA recall Z-0169-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-18

Class II · Terminated

Class II FDA medical device recall by Elekta, Inc., initiated 2012-09-18, terminated 2013-06-06. It names one FDA 510(k) clearance: K120067. 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.. 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: Elekta, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Terminated: 2013-06-06
Firm location: Norcross, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K120067 — MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc.·cleared 2012-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.