Medical device recalls Moderate risk

Elekta Impac Software recalls MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows…

Recall date
September 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1597-2020
FDA classification
Class II
Brand / firm
Elekta Impac Software
Sold / distributed
Worldwide distribution.

Why it was recalled

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

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 - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

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