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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