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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ OIS

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  Class 2 Device Recall MOSAIQ OIS see related information
Date Initiated by Firm December 02, 2016
Create Date December 09, 2016
Recall Status1 Terminated 3 on November 05, 2021
Recall Number Z-0731-2017
Recall Event ID 75853
510(K)Number K141572  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System

The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed.
Code Information Versions 2.60 an 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		 Edits to Particle field definition parameters may not be saved when the field definition window is saved.
FDA Determined
Cause 2		 Software design
Action The firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" letter dated 11/2016 was sent to affected customers on 12/2/2016. The letter describes the product, problem and actions to be taken. The customers were instructed to save and re-open the field definition form when manual edits have been performed to confirm that the edits were save; post this notice in a place accessible to all users; advise the appropriate personnel working with the product the content of the letter; and complete and return the Acknowledgement Form via fax to: 408 830 8003 immediately upon receipt but no later than 30 days. Elekta will resolve the problem with the MOSAIQ 2.60 SP7F, MOSAIQ 2.60 SP14 and 2.64 SP3. Customers are encouraged to contact Elekta support to get the corrected version. If you have any questions, contact RA Manager Americas at 1-770-300-9725 or email to: Elekta_Global_PMS@elekta.com.
Quantity in Commerce 47
Distribution Worldwide Distribution-US (nationwide) to states of: FL, IL, MO, NJ, OH, OK, TN, TX, VA, and countries of: Italy, Japan, South Korea, Sweden 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 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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