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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 MOSAIQsee related information
Date Initiated by FirmNovember 24, 2015
Create DateDecember 17, 2015
Recall Status1 Terminated 3 on September 15, 2021
Recall NumberZ-0447-2016
Recall Event ID 72725
510(K)NumberK141572 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Code Information Versions prior to 2.60.
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-670-2422
Manufacturer Reason
for Recall		First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
FDA Determined
Cause 2		Software design
ActionElekta sent an Urgent Important Field Safety Notice 371-01-MSQ-004 to all affected customers on 11/24/2015. The notice informs users to the issue, the work around and the solution. The customers are instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta Office or Representative, as soon as possible but no longer than 30 days from receipt.
Quantity in Commerce211
DistributionNationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IYE
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