27
Dec
2017

Cl II Xper Flex Cardio Physiomonitoring system

0

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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