Recall Z-1149-2013— Maquet Cardiovascular, LLC

Name: FDA recall Z-1149-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-07

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2013-03-07, terminated 2013-08-22. It names one FDA 510(k) clearance: K102726. 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).. 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 bl.

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Terminated: 2013-08-22
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K102726 — CARDIOHELP SYSTEMMaquet Cardiopulmonary, AG·cleared 2011-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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 bl

Data sourced from openFDA. This site is unofficial and independent of the FDA.