Company: Merge Healthcare, Inc.
Date of Enforcement Report 9/7/2016
Class lI:
PRODUCT
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.
Recall Number Z-2685-2016
REASON
Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite..
RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 8/29/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
96 sites potentially have the affected versions for both products
DISTRIBUTION
US Distribution to: CO and OK.
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