Cl II Xper Flex Cardio Physiomonitoring system

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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Software Verification

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.