The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Reason for recall: The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen. Distribution: Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA. Quantity: 62826 total devices Lot/code info: Model number: DS2000X11B, 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, H277423832B
606959052000
Official record: FDA (Device enforcement) ↗
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