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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 September 02, 2021
Create Date September 29, 2021
Recall Status1 Open3, Classified
Recall Number Z-2591-2021
Recall Event ID 88599
510(K)Number K183034  
Product Classification Accelerator, linear, medical - Product Code IYE
Product MOSAIQ Oncology Information System
Code Information MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)
Recalling Firm/
Manufacturer		 Elekta, Inc.
100 Mathilda Pl
5th Floor
Sunnyvale CA 94086-6076
For Additional Information Contact Mr. Chris Prince
408-203-7753
Manufacturer Reason
for Recall		 A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" dated August 2021 via email to its consignees on 9/2/2021. Recommendations were made to the user until a fix is available.
Quantity in Commerce 31
Distribution Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the 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 = Elekta, Inc
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