Date of Enforcement Report 6/13/2018
Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such.
Recall Number: Z-2115-2018
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Invivo Corporation, Orlando, FL on 11/20/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,040 units (USA) and 7 units (Foreign)
Nationwide and Internationally