Merge: Merge PACS software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 6/21/2017
Class lI:

PRODUCT

Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Recall Number Z-2590-2017

REASON
Merge PACS did not show unviewed images when the last view was skipped. There is a potential risk to health of a physician misdiagnosis because not all images are available for viewing.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 5/8/2017. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
47 sites potentially have the affected versions

DISTRIBUTION
Nationwide

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