Medical device recalls Moderate risk

Elekta, Inc. recalls MOSAIQ Oncology Information System

Recall date
July 15, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2293-2016
FDA classification
Class II
Brand / firm
Elekta, Inc.
Sold / distributed
Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom

Why it was recalled

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

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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