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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 July 15, 2016
Create Date July 27, 2016
Recall Status1 Open3, Classified
Recall Number Z-2293-2016
Recall Event ID 74668
510(K)Number K123230  
Product Classification Oncology Information System - Product Code IYE
Product MOSAIQ Oncology Information System
Code Information Versions 2.50.05 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-300-9725
Manufacturer Reason
for Recall		 It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.
FDA Determined
Cause 2		 Software Design Change
Action Elekta sent Important Field Safety Notice 371-03-MSQ-001 to all customers on 7/15/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. The letter also included a response form which is to be returned to Elekta.
Quantity in Commerce 383
Distribution Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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