Elekta, Inc.: MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Recall number

Z-1800-2014

Recalling firm

Elekta, Inc.

Product

MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.

Status

Terminated

Initiated

2014-05-23

Posted

2014-06-16

Terminated

2021-07-16

Reason

When using CMA, if the user hovers the mouse pointer exactly above the direction dropdowns and then uses the mouse thumbwheel or touchpad scroll bar, the direction selection might change when the intention was only to move the mouse to a different area of the screen.

Root cause

Software design

Action

Elekta sent an Important Safety Notice on May 23, 2014, to all affected customers. The notice identified the product the problem and the action needed to be taken by the customer. "Notify the affected customers of the issue - To be completed 06/22/2014 "Provide a fix to the defect in an expeditious timeframe. It is mandatory for all customers to apply the fix - Version 2.50.05 SP8 & Version 2.60 - To be released 05/16/2014 "Follow up with the affected customers for: -Confirmation receipt of the LIN, AND -Confirmation of installation of patch for the fix- To be completed 11/30/2014. For further questions please call (404) 993-5886.

Quantity

723

Distribution

Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gabon, Germany, Ghana, Greece, Honduras, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Libya, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine and Venezuela.

Lot, serial or model codes

N/A - Software versions 1.40 through 2.50, inclusive

510(k) numbers

["K123230"]

PMA numbers

not on file

Product code

IYE

Firm FEI

1037831

Firm city

Atlanta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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