Medical device recalls Moderate risk

Elekta, Inc. recalls MOSAIQ Oncology Information System

Recall date
August 3, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2917-2018
FDA classification
Class II
Brand / firm
Elekta, Inc.
Sold / distributed
AK, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, WA, WI, WV, and WY Australia, Canada, Ireland, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, and United Kingdom

Why it was recalled

Order Status Remains Approved When Should Indicate Complete.

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

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