Company: Merge Healthcare, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Merge Cardio software..
Recall Number Z-1486-2017

REASON
Cardio study list does not show STAT studies without refreshing.

RECALLING FIRM/MANUFACTURER
Merge Healthcare, Inc., Hartland, WI on 4/4/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
217 sites potentially have the affected accessory

DISTRIBUTION
USA (nationwide ) Distribution to medical facilities. Military distribution was also made. There was no foreign/government distribution.

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