Jun

2018

Xper Flex Cardio Physiomonitoring System: Cl II

Company:Invivo Corporation.
Date of Enforcement Report 6/13/2018
Class lI:

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
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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

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About the author

Amy Sellers

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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Xper Flex Cardio Physiomonitoring System: Cl II

Amy Sellers

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