Merge Healthcare, Inc. recalls RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribut…
- Recall date
- January 30, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2685-2016
- FDA classification
- Class II
- Brand / firm
- Merge Healthcare, Inc.
- Sold / distributed
- US Distribution to: CO and OK.
Why it was recalled
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite.
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. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
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