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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 December 04, 2018
Create Date December 27, 2018
Recall Status1 Open3, Classified
Recall Number Z-0686-2019
Recall Event ID 81705
510(K)Number K141572  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System Version 2.64.

MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
Code Information Software Build(s): 2.64 SP9 and higher;   UDI (01)00858164002091(10)2.64.235
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information Contact Alejandra Carrillo
404-202-4333
Manufacturer Reason
for Recall		 If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may not be the correct isocenter for imaging when it is sent to the machine.
FDA Determined
Cause 2		 Software design
Action Elekta notified customers on about 12/04/2018 via letter titled, "Urgent Important Field Safety Notification." The letter contains recommended user action and that appropriate personnel working with the device should be advised on the content of the letter and the letter should be placed in an area accessible to all users. The letter stated that the issue will be resolved in Service Packs to MOSAIQ Releases 2.64, 2.65 and 2.70. Customers will be informed when the fix is available through a Product Bulletin. An acknowledgement Form was sent as part of the letter to be completed and returned no later than 30 days. The firm can be contacted at 408-830-8000 or 855-693-5358.
Quantity in Commerce 551 units
Distribution Distributed in the United States and outside of the Unites States: Algeria; Antigua and Barbuda; Argentina; Australia; Belgium; Botswana; Brazil; Canada; China; Colombia; Denmark; France; Germany; India; Indonesia; Iran; Ireland; Israel; Italy; Japan; Latvia; Lebanon; Malaysia; Mexico; Morocco; Myanmar; Netherlands; New Zealand; Norway; Peru; Philippines; Poland; Portugal; Russian Federation; Rwanda; Saudi Arabia; Senegal; Singapore; Slovenia; South Africa; Spain; Sweden; Switzerland; Taiwan; Thailand; Turkey; United Kingdom; Viet Nam
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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