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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 September 24, 2019
Date Posted March 26, 2020
Recall Status1 Open3, Classified
Recall Number Z-1597-2020
Recall Event ID 85240
510(K)Number K141572  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Code Information Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)
Recalling Firm/
Manufacturer		 Elekta Impac Software
100 Mathilda Pl Fl 5
Sunnyvale CA 94086-6017
Manufacturer Reason
for Recall		 The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
FDA Determined
Cause 2		 Software design
Action The firm began notifying their consignee on 09/24/2019 by email. The notice explained the issue and provided a workaround for the consignee to use until the updated software is ready for release.
Quantity in Commerce 3732 units
Distribution Worldwide distribution.
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 = MUJ and Original Applicant = IMPAC MEDICAL SYSTEMS, INC.
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