Elekta, Inc. recalls MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment plan…

Recall date

December 9, 2015

Source

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

Recall number

Z-0557-2016

FDA classification

Class II

Brand / firm

Elekta, Inc.

Sold / distributed

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, Austri…

Why it was recalled

Incorrect drug dosage due to "Age Limit" and patient weight data item issue.

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 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.