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Elekta, Inc. recalls MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment pl
Recalled January 6, 2016 · FDA recall Z-0557-2016 · Elekta
Hazard
Incorrect drug dosage due to "Age Limit" and patient weight data item issue. · FDA Class II
Units
399
Sold at
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.
Description
Incorrect drug dosage due to "Age Limit" and patient weight data item issue.
Product
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.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →