221 results
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68ms
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Sources: EU EUDAMED, US FDA
(STOCKERT) SORIN GROUP DEUTSCHLAND GMBH
FDA Adverse Event
Injury
·BORIN GROUP·Product code DWB·July 8, 2005
SORIN CENTRIFUGAL PUMP SYSTEM SCP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND GMBH·Product code DWA·November 20, 2015
SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012
Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·August 25, 2016
S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany. Used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DTQ·November 12, 2010
CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND GMBH·Product code DWA·July 16, 2015
S3 UPS CHARGING MODULE
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND GMBH·Product code DTQ·July 8, 2015
S5 ROLLER PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND GMBH·Product code DTQ·July 21, 2015
HEATER COOLER SYSTEM 3T
FDA Adverse Event
Injury
·SORIN GROUP DEUTSCHLAND GMBH·Product code DWC·August 13, 2015