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Carefusion 211 Inc Recalls
14 recalls on record · October 9, 2013 to June 22, 2016 · Medical Devices
Recalls by year
13
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patie
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum p
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum pat
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assi
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing b
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechani
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically cont
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically cont
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist br
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 22, 2016Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or ass
Hazard: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
June 3, 2015Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanicall
Hazard: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
October 9, 2013Medical DevicesFDA
Carefusion 211 Inc dba Carefusion recalls Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 o
Hazard: CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.