Merge PACS software Cl II

Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/17/2016
Class lI:

PRODUCT

Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Recall Number Z-2379-2016

REASON
The patient name in the Halo title bar and the thumbnails do not match the name on displayed images.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc, Hartland, WI on 1/20/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
93 sites have the affected version

DISTRIBUTION
The software was distributed to medical facilities nationwide. Government distribution was made to MN. Foreign distribution was made to Australia and to the United Kingdom. There was no military distribution

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.