Company: Merge Healthcare, Inc.
Date of Enforcement Report 8/31/2016
Class lI:
PRODUCT
NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product Usage NovaPACS is a picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation,
Recall Number Z-2659-2016
REASON
Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport..
RECALLING FIRM/MANUFACTURER
Novarad Corporation, American Fork, UT on 8/25/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
90
DISTRIBUTION
Nationwide and Internationally
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