863 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
FDA Recall
Terminated
·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DWA·August 26, 2019
CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel. It used with an Electrical Remote-Controlled (ERC) tubing clamp and a bubble sensor.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DWA·October 30, 2017
Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code DWA·April 21, 2010
Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
FDA Recall
Terminated
·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DWA·August 26, 2019
CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DWA·December 4, 2013
Pump control panel. The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
FDA Recall
Terminated
·Sorin Group Deutschland GmbH Lindberghstrasse 25 Munchen Germany·Product code DWA·February 23, 2012
SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DWA·September 20, 2012
SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less.
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DWA·September 20, 2012
Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used in an HLM S5/C5 System configuration. A cardiopulmonary bypass speed control device.
FDA Recall
Terminated
·LivaNova Deutschland GmbH Lindberghstr. 25 Munich Germany·Product code DWA·December 17, 2021
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
FDA Recall
Terminated
·Cardiac Assist, Inc·Product code DWA·July 21, 2022
SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
FDA Recall
Terminated
·Cardiac Assist, Inc·Product code DWA·December 5, 2022
Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
FDA Enforcement
Class II
·Terminated·Covidien LLC·July 29, 2015
MAS Omni Immune Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
MAS Omni Immune PRO Controls
FDA Enforcement
Class III
·Terminated·Microgenics Corporation·July 2, 2014
da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System. Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
FDA Enforcement
Class II
·Terminated·Intuitive Surgical, Inc.·February 11, 2015
MAS Omni Immune Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
MAS Omni Immune PRO Controls
FDA Recall
Terminated
·Microgenics Corporation·Product code JJY·December 2, 2013
AXIOM Artis dBA, Model Number 7555357
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
AXIOM Artis dBA, Model Number 7555357
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code OWB·June 12, 2019
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L bottles, Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories·Product code GGK·December 19, 2007