Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/1/2017
Class lI:

PRODUCT

Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
Recall Number Z-1246-2017

REASON
Eye Station images were not importing properly and were imported under “unknown” due to an issue when validating patients using only an Medical Record Number (MRN)

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 3/28/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,627 sites potentially have the affected versions

DISTRIBUTION
Nationwide and Internationally

___________________________________