Company: Merge Healthcare Inc.
Date of Enforcement Report 1/6/2016
Class lI:
PRODUCT
Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
Recall Number Z-0554-2016
REASON
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house..
RECALLING FIRM/MANUFACTURER
Merge Healthcare Inc., Hartland, WI on 10/26/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
Distributed in the states of IL, NC, and VT.
___________________________________