Date of Enforcement Report 12/27/2017
Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such..
Recall Number Z-0263-2018
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Invivo Corporation, Orlanda, FL on 8/182017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally