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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 Systemsee related information
Date Initiated by FirmDecember 09, 2015
Create DateDecember 29, 2015
Recall Status1 Terminated 3 on September 27, 2022
Recall NumberZ-0557-2016
Recall Event ID 72801
510(K)NumberK141572 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Code Information Versions 2.50 and higher
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactLinda Wetsel
770-300-9725
Manufacturer Reason
for Recall		Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
FDA Determined
Cause 2		Software design
ActionThe firm, Elekta, sent an "URGENT IMPORTANT FIELD SAFETY NOTICE 371-01-MSQ-005" to all customers on 12/9/2015. The notice informs users of the specific product and version numbers affected by both issues, also includes a workaround for both issues. A copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers are instructed to return the acknowledgement form to their local Elekta as soon as possible-Fax: 408-830-8003. If you have any queries about this Notice, please contact your local Elekta office, call 408-830-8000 or toll free: 855-693-5358 or www.elekta.com.
Quantity in Commerce399
DistributionWorldwide Distribution: US (nationwide) including states of: 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, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.
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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