FDA Device Recalls

Class ITerminated

Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostream"20p Patient Monitor. The battery pack powers the monitor when AC power is not available or when monitoring is required during intra-hospital transfer of patients. The Capnostream"20 and Capnostream"20p is a combined capnograph/pulse oximeter monitor and its accessories are intended to provide professionally trained health care providers with continuous, non-invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital transport environments

Medtronic

Medtronic Respiratory & Monitoring Solutions Announces a Voluntary Recall of a Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor Due to the Battery Pack Might Experience Thermal Runaway with the Potential of Fire Risk to the Monitor.

April 13, 2016 · DeviceView details →

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.

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.

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.