Medical device recalls Moderate risk

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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