Cl ll MAQUET CARDIOHELP Support System

Company: Maquet Cardiovascular, LLC.
Date of Enforcement Report: 4/24/2013
Class ll:

PRODUCT

MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through 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-1149-2013

REASON
It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of blood flow which is set by a separate rotary knob located at the front of the device.

RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular, LLC, Wayne, NJ on 3/7/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
154 units

DISTRIBUTION
Nationwide and Internationally

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