FDAFDA · Food and drugs·Recall number Z-1149-2013
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).
Published April 24, 2013 · Recall initiated: March 7, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- Worldwide Distribution - USA Nationwide and the following countries: Australia, Austria, Belarus, Belgium, Canada, Columbia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Iceland, Iran, Ireland, Italy, Jordan, Kazakhstan, Korea, Kuwait, Luxembourg, The Netherlands, Norway, Oman, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and the United Kingdom.
- Lot
- Catalog Number: 70104.8012 Cardiohelp-i. Multiple serial numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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