Merge Healthcare, Inc. recalls Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall date
- April 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1176-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distribution was made to medical facilities in AZ, CA, CO, FL, HI, IL, MA, MD, MI, MO, NY, OH, PA, SC, TN, UT, and WI. There was no foreign/government/military distribution.
Why it was recalled
Potential exists for an incorrect patient image being displayed which could result in the 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 PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
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