Medical device recalls Moderate risk

Merge Healthcare, Inc. recalls Fusion Workstation.; Indicated for the transmission and review of radiological images.

Recall date
October 28, 2011
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0294-2017
FDA classification
Class II
Brand / firm
Merge Healthcare, Inc.
Sold / distributed
Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.

Why it was recalled

After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

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

What was recalled

Fusion Workstation.; Indicated for the transmission and review of radiological images.

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