266 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·August 1, 2005
Terumo Advanced Perfusion System 1- 4" Roller Pump for Terumo System 1 Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·November 10, 2011
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·September 25, 2012
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2006
Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 12, 2004
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 6, 2005
Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·October 16, 2003
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·April 1, 2004
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004
Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DTQ·July 1, 2004
Jostra HL-20 Heart Lung Machine - guiding pins
FDA Recall
Terminated
·MAQUET Inc.·Product code DTQ·October 3, 2006
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·May 3, 2011
Cardiovascular Procedure Kit Part number 70667-01 Eisenhower Army Med Center Heart Lung Pack, Sterile, Terumo Cardiovascular Systems Ashland, MA. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·May 3, 2011
Large Roller Pump 6" Diameter, Catalog 801041, Terumo Cardiovascular Systems, Corp., Ann Arbor, MI The product is indicated for up to 6 hours of extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary bypass procedures when used by a qualified medical professional.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 31, 2011
Roller Pump, 4 Inch Diameter The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 13, 2012
SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-60 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
Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also provide two digital timers. The pressure channel can have alert and alarm levels set by the user to indicate overpressure conditions. The alert and alarm level settings are retained by the system and can be recalled after the next power up. Alert and alarm conditions are indicated by flashing LED bar with single or dual audio tones; an alarm will also stop the arterial and cardioplegia pumps.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 21, 2012