The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Reason for recall: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation. Distribution: US Nationwide. Global Distribution. Quantity: 22,237 devices Lot/code info: UDI-DI: 606959052000; Serial Numbers: H27736231F4BE H277362379188 H27736246CD09 H277372867812 H27737288916C H2773729661CA H27737302AA2A H27737306EC0E H2773730914F9 H27737331B2D9 H27737344A87C H277373468B6E H277373596A41 H277373815671 H2773738401DC H2773740998FC H277374132E7E H277374212704 H277374525897 H277374740E11 H277374848DD9 H27737492F137 H27737496B713 H277375206C51 H277375242A75 H2773757677DF H277375789EA1 H27737583A3BA H27737593BA62 H27737607C43A H27737614EF79 H27737624C511 H27737635CD40 H27737646B2D3 H27737656AB0B H27737664A271 H2773767871C5 H277376870AFA H27737700EA59 H27737702C94B H277378459053 H27737846A2C8 H27737847B341 H27737853ECBD H277378549802 H27737869698F H277378779929 H277378925494 H277378970339 H2773792845BA H27737966CBA4 H27737971A6C3 H277379821790 H2773801950BC H27738021F69C H277380378A72 H27738043815E H27738052890F H27738057DEA2 H277380680C3D H277380801A65 H277380867F53 H27738088962D H277380933126 H277381019FF0 H2773814974D8 H27738152D3D3 H27738154B6E5 H277381587C89 H27738160DAA9 H27738171D2F8 H27738176A647 H27738177B7CE H27738188CCF1 H277381963C57 H27742204CB4B H27742215C31A H27742217E008 H27742227CA60 H27742236C231 H27742240EA0F H27742245BDA2 H27742251E25E H27742262FAAD H27742273F2FC H2774229368EC H27742305801E H277423085BFB H27742321F58A H277423378964 H2774234293C1 H27742362A071 H277423691EA2 H27742377EE04 H277423823A61 H277423832BE8 H27742396659D H277424050C1B H277424072F09 H277424242E22 H277424253FAB H277424260D30 H27742428E44E H27742429F5C7 H27742
606959052000
Official record: FDA (Device enforcement) ↗
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