Company: Invivo Corporation.
Date of Enforcement Report 6/13/2018
Class II:
PRODUCT
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
REASON
While in Full Disclosure playback, a user may inadvertently close the Full Disclosure Control Window using the ESC key function, instead of pressing the X icon in the upper right corner of this window..
RECALLING FIRM/MANUFACTURER
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)
DISTRIBUTION
Nationwide and Internationally