Company: AGFA Healthcare Corp.. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats Recall Number Z-2652-2017 REASON A customer experienced when...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 7/5/2017 Class lI: PRODUCT Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are...Read More