Merge Healthcare, Inc. recalls Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall date
- November 17, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1180-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- US Distribution was made to medical facilities in AL, IN, MI, PA and WI.
Why it was recalled
The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
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