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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 June 17, 2016
Create Date June 27, 2016
Recall Status1 Terminated 3 on August 18, 2020
Recall Number Z-2052-2016
Recall Event ID 74378
510(K)Number K141572  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System
Code Information Versions 2.62 and higher
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		 It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
FDA Determined
Cause 2		 Software design
Action Elekta sent an Important Field Safety Notice to all customers on June 17, 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. A software patch will be issued for Mosaiq version 2.62 in order to the correct the defect. For further questions please call (404) 993-5886.
Quantity in Commerce 69
Distribution US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of : Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, 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 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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