Merge Healthcare, Inc. recalls Merge Cardio with software version 10.1 LA.
- Recall date
- October 26, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0555-2016
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- Distributed in the states of IL, NC, and VT.
Why it was recalled
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
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 Cardio with software version 10.1 LA.
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