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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 August 03, 2018
Create Date August 23, 2018
Recall Status1 Open3, Classified
Recall Number Z-2917-2018
Recall Event ID 80764
510(K)Number K141572  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System
Code Information Software Build(s) 2.64 SP3 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Customer Service
855-693-5358
Manufacturer Reason
for Recall		 Order Status Remains Approved When Should Indicate Complete.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On August 2018 the firm sent letter to all their customer with the following instructions; Recommended User Action: A user with appropriate pharmacy rights can unlock the record. This blanks out the details requiring the user to re-enter the administration details previously entered. To avoid this locking issue, close the MAR window before navigating to the CWS. This document contains important information for the continued safe and proper use of your equipment. ¿ Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. ¿ Advise the appropriate personnel working with this product the content of this letter. Elekta Corrective Actions: The issue is resolved in MOSAIQ Release 2.65 Beta 02 and in release 2.64 SP10. In order to meet regulatory requirements, you are required to complete this the Acknowledgement Form and return it to Elekta immediately upon receipt but no later than 30 days.
Quantity in Commerce 185
Distribution AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, 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 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 and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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