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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ Oncology Information System

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  Class 2 Device Recall MOSAIQ Oncology Information System see related information
Date Initiated by Firm July 01, 2015
Date Posted July 14, 2015
Recall Status1 Terminated 3 on September 15, 2021
Recall Number Z-2063-2015
Recall Event ID 71573
510(K)Number K141572  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System
MOSAIQ is 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 Software Version 2.41 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Linda Wetsel
770-670-2422
Manufacturer Reason
for Recall		 A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
FDA Determined
Cause 2		 Software design
Action Elekta sent an Urgent Important Field Safety Notice 371-01-MSQ-003 on July 1, 2015, to all affected customers. The notice informed users of the specific product and version numbers affected and that the problem only exists if all the following criteria is met - (1) Running Mosaiq 2.41; (2) with at least one linac equipped with an Agility 160 MLC head (Versa HD, Infinity, Axesse (EOS) or Synergy); and (3) who are treating with Stereotactic Cones. The notice also advises users of the workaround to avoid the problem. The customers were also instructed to return the Important Field Safety Notice Acknowledgment form. For questions regarding this recall call 770-670-2422.
Quantity in Commerce 74 Total (45 US)
Distribution Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, 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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