28 results
·
58ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·April 3, 2015
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Recall
Terminated
·Carefusion 211 Inc dba Carefusion·Product code CBK·May 17, 2016
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
FDA Enforcement
Class I
·Terminated·Carefusion 211 Inc dba Carefusion·June 22, 2016