Terminated

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.

FDA Recall Z-1800-2014 · Posted 2014-06-16

Recalling FirmElekta, Inc.

Recall StatusTerminated

Product CodeIYE

Date Initiated2014-05-23

Date Terminated2021-07-16

Product Quantity723

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123230MOSAIQ ONCOLOGY INFORMATION SYSTEMImpac Medical Systems, Inc. · 2012-12-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.