Class 2 Device Recall MOSAIQ

• Date Initiated by Firm: November 03, 2014
• Date Posted: November 15, 2014
• Recall Status: Terminated on July 27, 2015
• Recall Number: Z-0221-2015
• Recall Event ID: 69656
• 510(K)Number: K123230
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
• Code Information: MOSAIQ Release 2.60.257
• 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: A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports.
• FDA Determined Cause: Software design
• Action: Elekta sent an Urgent Important Field Safety Notice letter to alert customers of the issue. This notice was distributed on November 3, 2014. A fix to the defect has been developed and has been released by Product Creation. For question call 408-830-8000.
• Quantity in Commerce: 15
• Distribution: US Nationwide Distribution in the states of AZ. CO, IL, MD, MO, NY, OK, OR, PA, RI, TX, VA
• 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