FDAFDA · Food and drugs·Recall number Z-0557-2016
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.
Published January 6, 2016 · Recall initiated: December 9, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Elekta, Inc.
- Distributor
- 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.
- Lot
- Versions 2.50 and higher
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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