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Elekta, Inc. recalls MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Recalled December 23, 2015 · FDA recall Z-0447-2016 · Elekta
Hazard
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 Class II
Units
211
Sold at
Nationwide 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.
Description
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.
Product
MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →