Elekta, Inc. recalls MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

Recall date

November 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0447-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.