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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ

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  Class 2 Device Recall MOSAIQ see related information
Date Initiated by Firm May 23, 2014
Date Posted June 16, 2014
Recall Status1 Terminated 3 on July 16, 2021
Recall Number Z-1800-2014
Recall Event ID 68355
510(K)Number K123230  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information N/A - Software versions 1.40 through 2.50, inclusive
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter Ne
Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
404-993-5886
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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