Company:Invivo Corporation
Date of Enforcement Report 12/27/2017
Class lI:
PRODUCT
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
REASON
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
RECALLING FIRM/MANUFACTURER
Invivo Corporation, Orlanda, FL on 8/182017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
4,535
DISTRIBUTION
Nationwide and Internationally
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