Company: Merge Healthcare Inc.
Date of Enforcement Report 1/6/2016
Merge Cardio with software version 10.1 LA.
Recall Number Z-0555-20166
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.
Merge Healthcare Inc., Hartland, WI on 10/26/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Distributed in the states of IL, NC, and VT.