Merge Healthcare, Inc. recalls iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
- Recall date
- April 4, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1470-2017
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- USA (nationwide ) Distribution to medical facilities. Government distribution was also made. There was no foreign or military distribution.
Why it was recalled
The software produced a number of "do not route" exceptions, 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
iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare.
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