MOSAIQ 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.
FDA Recall Z-0557-2016 · Posted None
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2015-12-09
Date Terminated2022-09-27
Product Quantity399
Reason for Recall
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Firm Action
The 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.
Root Cause
Software design
Distribution Pattern
Worldwide 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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