Merge Healthcare, Inc. recalls RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Recall date
- May 6, 2013
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2796-2016
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distribution was nationwide to medical facilities. Government distribution was made to LA and OK.
Why it was recalled
Multiple studies were missing at a customer location that never made it to the archive before watermarking
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
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