19
Nov
2014

Cl II Maquet Cardiohelp-I System

0

Company:Maquet Cardiovascular Us Sales, Llc.
Date of Enforcement Report 11/19/2014
Class lI:

PRODUCT

Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
Recall Number Z-0211-2015

REASON
Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a “Battery Needs Service” message after startup of the units when using either AC or DC power

RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular Us Sales, Llc, Wayne NJ on 10/17/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
331 units

DISTRIBUTION
Nationwide

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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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