Class 2 Device Recall MOSAIQ

• Date Initiated by Firm: July 15, 2016
• Create Date: July 27, 2016
• Recall Status: Open, 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: 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