Draeger Atlan Anesthesia Workstation (Draeger) – Ventilation Failure (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Brand
Draeger Medical, Inc.
Lot Codes / Batch Numbers
Model/Catalog Number: 8211500, UDI-DI Number: 04048675556176, Serial Numbers Distributed in the US: ASTB-0038, 0039, 0146, 0147, 0148, 0281, 0282, 0283, 0300, 0301, 0302, 0303, 0312, 0313, 0314, 0315, 0316 ASTC-0005, 0094, 0095, 0190, 0191 ASTD-0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046 0057, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0148, 0149, 0150, 0151, 0152, 0153, 0155, 0156, 0157, 0158, 0170, 0171, 0186, 0235, 0236, 0237, 0257, 0258, 0259 ASTE-0002, 0003, 0004, 0005, 0006, 0007, 0008, 0029, 0030, 0031, 0032, 0080, 0134, 0135, 0136, 0152, 0153, 0154, 0155, 0180, 0181, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0254, 0255, 0318, 0319, 0320, 0321, 0322 ASTF-0007, 0008, 0009, 0010, 0145, 0146, 0147, 0148, 0149, 0150, 0177, 0178, 0379, 0380 ASTH-0083, 0084, 0107, 0160, 0161, 0184, 0185, 0207, 0208, 0233, 0241, 0242, 0254, 0370, 0392, 0432, 0464 Serial Numbers Distributed OUS ASTA-0279, 0293, 0302, 0303, 0304, 0306, 0334, 0335, 0336, 0344, 0347, 0348, 0360, 0369, 0373, 0375, 0376, 0377, 0379, 0380, 0381, 0386, 0389, 0390, 0392, 0393, 0399, 0412, 0422, 0433, 0435, 0437, 0438 ASTB-0009, 0011, 0012, 0015, 0016, 0017, 0019, 0024, 0025, 0026, 0027, 0035, 0036, 0042, 0043, 0044, 0045, 0047, 0050, 0056, 0058, 0059, 0060, 0062, 0067, 0069, 0070, 0072, 0073, 0085, 0086, 0087, 0088, 0089, 0090, 0091, 0092, 0096, 0097, 0098, 0099, 0100, 0101, 0102, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0123, 0124, 0125, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0147, 0149, 0152, 0153, 0154, 0155, 0156, 0157, 0158, 0159, 0163, 0164, 0166, 0167, 0168, 0169, 0170, 0171, 0172, 0173, 0174, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0207, 0208, 0209, 0210, 0212, 0213, 0221, 0222, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0245, 0246, 0247, 0251, 0252, 0253, 0254, 0255, 0256, 0257, 0258, 0259, 0260, 0261, 0267, 0268, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0284, 0285, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0299, 0301, 0310, 0311, ASTC-0009, 0010, 0011, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0027, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0043, 0044, 0045, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0065, 0066, 0067, 0071, 0072, 0073, 0074, 0075, 0076, 0084, 0085, 0086, 0087, 0088, 0096, 0097, 0098, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0120, 0121, 0122, 0128, 0129, 0130, 0131, 0132, 0134, 0135, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0155, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0164, 0165, 0166, 0167, 0168, 0170, 0171, 0172, 0188, 0189, 0193, 0197, 0198, 0199, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0246, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0257, 0258, 0259, 0260, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0276, 0277 ASTD-0001, 0002, 0003, 0004, 0005, 0006, 0007, 0017, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0047, 0048, 0049, 0053, 0054, 0055, 0056, 0058, 0059, 0060, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0077, 0078, 0079, 0104, 0105, 0106, 0107, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0125, 0126, 0127, 0128, 0177, 0178, 0179, 0180, 0184, 0185, 0196, 0197, 0198, 0199, 0200, 0201, 0202, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0220, 0221, 0222, 0223, 0224, 0234, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0260, 0261, 0262, 0263, 0264, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0276, 0277, 0278, 0279, 0280, 0281, 0282, 0283, 0284 ASTE-0009, 0010, 0011, 0018, 0019, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0027, 0028, 0033, 0036, 0037, 0038, 0039, 0040, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0061, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0075, 0076, 0081, 0082, 0088, 0089, 0090, 0091, 0092, 0093, 0094, 0095, 0096, 0097, 0098, 0099, 0100, 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0109, 0110, 0111, 0112, 0113, 0114, 0115, 0116, 0117, 0118, 0119, 0120, 0121, 0132, 0133, 0137, 0138, 0139, 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0150, 0151, 0156, 0157, 0158, 0159, 0160, 0161, 0162, 0167, 0168, 0169, 0170, 0182, 0183, 0184, 0185, 0186, 0188, 0189, 0190, 0191, 0192, 0193, 0194, 0204, 0205, 0206, 0207, 0208, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0251, 0252, 0253, 0256, 0257, 0258, 0259, 0260, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0276, 0277, 0283, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0307, 0308, 0309, 0310, 0311, 0312, 0313, 0314, 0315, 0316, 0317, 0323, 0324, 0330, 0331, 0332, 0333, 0334, 0335, 0336, 0337, 0338, 0339, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0347, 0363, 0364, 0365, 0366, 0367, 0368, 0369, 0376 ASTF-0011, 0012, 0013, 0020, 0021, 0022, 0023, 0024, 0025, 0026, 0038, 0039, 0040, 0041, 0042, 0043, 0044, 0045, 0046, 0047, 0056, 0057, 0058, 0059, 0060, 0064, 0065, 0066, 0067, 0068, 0069, 0083, 0084, 0085, 0087, 0088, 0089, 0090, 0091, 0092, 0094, 0095, 0096, 0097, 0098, 0099, 0100, 0101, 0102, 0103, 0104, 0105, 0106, 0107, 0108, 0109, 0114, 0115, 0116, 0117, 0120, 0126, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0142, 0143, 0144, 0152, 0153, 0154, 0156, 0157, 0158, 0159, 0160, 0161, 0163, 0164, 0165, 0171, 0172, 0173, 0174, 0175, 0176, 0179, 0180, 0181, 0182, 0183, 0184, 0185, 0186, 0187, 0188, 0189, 0190, 0191, 0192, 0193, 0199, 0200, 0201, 0202, 0203, 0204, 0205, 0206, 0207, 0208, 0209, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0217, 0218, 0219, 0223, 0224, 0225, 0226, 0227, 0228, 0229, 0230, 0231, 0232, 0233, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0241, 0242, 0243, 0244, 0245, 0246, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0254, 0255, 0256, 0257, 0258, 0259, 0260, 0261, 0262, 0263, 0264, 0265, 0266, 0267, 0268, 0269, 0270, 0271, 0272, 0273, 0274, 0275, 0276, 0277, 0278, 0279, 0280, 0281, 0282, 0283, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0293, 0294, 0295, 0296, 0297, 0298, 0299, 0300, 0302, 0303, 0304, 0305, 0306, 0307, 0308, 0309, 0310, 0311, 0312, 0313, 0314, 0315, 0316, 0317, 0318, 0319, 0320, 0321, 0322, 0323, 0324, 0325, 0326, 0327, 0328, 0329, 0330, 0331, 0332, 0333, 0334, 0335, 0336, 0337, 0338, 0339, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0347, 0348, 0349, 0350, 0351, 0352, 0353, 0354, 0355, 0356, 0357, 0358, 0359, 0360, 0361, 0362, 0363, 0364, 0365, 0366, 0367, 0368, 0369, 0370, 0371, 0372, 0373, 0374, 0375, 0376, 0377, 0378, 0381, 0382, 0383, 0384, 0385, 0386, 0387, 0388, 0389, 0390, 0391, 0392, 0393, 0394, 0395, 0396, 0397, 0398, 0399, 0400, 0401, 0402, 0403, 0404, 0405, 0407, 0408, 0412, 0413, 0414, 0415, 0416, 0417, 0418, 0419, 0420, 0421, 0422, 0423, 0424, 0425, 0426, 0427, 0428, 0429, 0430, 0431, 0432, 0433, 0439, 0440, 0441, 0442, 0443, 0444, 0445, 0446, 0447, 0448, 0449, 0450, 0451, 0452, 0453, 0454, 0455, 0456, 0457, 0458, 0459, 0460, 0461, 0462, 0463, 0464, 0465, 0466, 0467, 0468, 0469, 0470 ASTH-0004, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0022, 0028, 0029, 0030, 0031, 0032, 0033, 0034, 0035, 0036, 0037, 0038, 0048, 0049, 0050, 0051, 0052, 0053, 0054, 0055, 0056, 0057, 0058, 0059, 0060, 0061, 0062, 0063, 0064, 0065, 0066, 0067, 0068, 0069, 0070, 0071, 0072, 0073, 0074, 0077, 0078, 0079, 0080, 0085, 0086, 0087, 0089, 0090, 0091, 0100, 0101, 0102, 0103, 0104, 0105, 0106, 0108, 0109, 0110, 0111, 0112, 0113, 0114, 0127, 0128, 0129, 0130, 0131, 0132, 0133, 0134, 0135, 0136, 0137, 0138, 0139, 0140, 0141, 0154, 0155, 0156, 0157, 0158, 0159, 0162, 0163, 0164, 0165, 0166, 0167, 0168, 0177, 0178, 0179, 0180, 0181, 0182, 0183, 0199, 0200, 0201, 0202, 0203, 0205, 0206, 0210, 0211, 0212, 0213, 0214, 0215, 0216, 0231, 0232, 0234, 0235, 0236, 0237, 0238, 0239, 0240, 0247, 0248, 0249, 0250, 0251, 0252, 0253, 0262, 0263, 0264, 0265, 0268, 0283, 0284, 0285, 0286, 0287, 0288, 0289, 0290, 0291, 0292, 0300, 0301, 0321, 0322, 0323, 0340, 0341, 0342, 0343, 0344, 0345, 0346, 0347, 0348, 0349, 0350, 0351, 0352, 0353, 0354, 0366, 0367, 0368, 0369, 0371, 0372, 0373, 0374, 0375, 0376, 0377, 0378, 0379, 0380, 0381, 0391, 0397, 0398, 0399, 0400, 0402, 0411, 0433, 0438, 0439, 0454, 0455, 0456, 0457, 0458, 0459, 0460, 0461, 0462, 0463, 0471, 0472, 0473, 0474, 0475, 0482, 0483 ASTJ-0026, 0027, 0028, 0029, 0030, 0073, 0074, 0075, 0076, 0103, 0162, 0197, 0198, 0199, 0200, 0208, 0256 ASTK-0003, 0004, 0005, 0006, 0007, 0008, 0009
Products Sold
Model/Catalog Number: 8211500; UDI-DI Number: 04048675556176; Serial Numbers Distributed in the US: ASTB-0038; 0039; 0146; 0147; 0148; 0281; 0282; 0283; 0300; 0301; 0302; 0303; 0312; 0313; 0314; 0315; 0316 ASTC-0005; 0094; 0095; 0190; 0191 ASTD-0029; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0043; 0044; 0045; 0046 0057; 0136; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0148; 0149; 0150; 0151; 0152; 0153; 0155; 0156; 0157; 0158; 0170; 0171; 0186; 0235; 0236; 0237; 0257; 0258; 0259 ASTE-0002; 0003; 0004; 0005; 0006; 0007; 0008; 0029; 0030; 0031; 0032; 0080; 0134; 0135; 0136; 0152; 0153; 0154; 0155; 0180; 0181; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0254; 0255; 0318; 0319; 0320; 0321; 0322 ASTF-0007; 0008; 0009; 0010; 0145; 0146; 0147; 0148; 0149; 0150; 0177; 0178; 0379; 0380 ASTH-0083; 0084; 0107; 0160; 0161; 0184; 0185; 0207; 0208; 0233; 0241; 0242; 0254; 0370; 0392; 0432; 0464 Serial Numbers Distributed OUS ASTA-0279; 0293; 0302; 0303; 0304; 0306; 0334; 0335; 0336; 0344; 0347; 0348; 0360; 0369; 0373; 0375; 0376; 0377; 0379; 0380; 0381; 0386; 0389; 0390; 0392; 0393; 0399; 0412; 0422; 0433; 0435; 0437; 0438 ASTB-0009; 0011; 0012; 0015; 0016; 0017; 0019; 0024; 0025; 0026; 0027; 0035; 0036; 0042; 0043; 0044; 0045; 0047; 0050; 0056; 0058; 0059; 0060; 0062; 0067; 0069; 0070; 0072; 0073; 0085; 0086; 0087; 0088; 0089; 0090; 0091; 0092; 0096; 0097; 0098; 0099; 0100; 0101; 0102; 0104; 0105; 0106; 0107; 0108; 0109; 0110; 0111; 0112; 0113; 0114; 0115; 0116; 0117; 0118; 0119; 0120; 0121; 0123; 0124; 0125; 0126; 0127; 0128; 0129; 0130; 0131; 0132; 0133; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0144; 0145; 0147; 0149; 0152; 0153; 0154; 0155; 0156; 0157; 0158; 0159; 0163; 0164; 0166; 0167; 0168; 0169; 0170; 0171; 0172; 0173; 0174; 0183; 0184; 0185; 0186; 0187; 0188; 0189; 0190; 0191; 0192; 0193; 0194; 0196; 0197; 0198; 0199; 0200; 0201; 0202; 0203; 0204; 0205; 0207; 0208; 0209; 0210; 0212; 0213; 0221; 0222; 0223; 0224; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245; 0246; 0247; 0251; 0252; 0253; 0254; 0255; 0256; 0257; 0258; 0259; 0260; 0261; 0267; 0268; 0269; 0270; 0271; 0272; 0273; 0274; 0275; 0284; 0285; 0292; 0293; 0294; 0295; 0296; 0297; 0298; 0299; 0301; 0310; 0311; ASTC-0009; 0010; 0011; 0012; 0013; 0014; 0015; 0016; 0017; 0018; 0019; 0020; 0021; 0022; 0023; 0024; 0027; 0028; 0029; 0030; 0031; 0032; 0033; 0034; 0035; 0043; 0044; 0045; 0051; 0052; 0053; 0054; 0055; 0056; 0057; 0058; 0059; 0060; 0061; 0065; 0066; 0067; 0071; 0072; 0073; 0074; 0075; 0076; 0084; 0085; 0086; 0087; 0088; 0096; 0097; 0098; 0110; 0111; 0112; 0113; 0114; 0115; 0116; 0117; 0120; 0121; 0122; 0128; 0129; 0130; 0131; 0132; 0134; 0135; 0141; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0149; 0155; 0156; 0157; 0158; 0159; 0160; 0161; 0162; 0164; 0165; 0166; 0167; 0168; 0170; 0171; 0172; 0188; 0189; 0193; 0197; 0198; 0199; 0204; 0205; 0206; 0207; 0208; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0231; 0232; 0233; 0234; 0235; 0236; 0237; 0238; 0239; 0240; 0241; 0246; 0247; 0248; 0249; 0250; 0251; 0252; 0253; 0254; 0255; 0256; 0257; 0258; 0259; 0260; 0261; 0262; 0263; 0264; 0265; 0266; 0267; 0268; 0269; 0270; 0271; 0272; 0273; 0274; 0275; 0276; 0277 ASTD-0001; 0002; 0003; 0004; 0005; 0006; 0007; 0017; 0018; 0019; 0020; 0021; 0022; 0023; 0024; 0025; 0047; 0048; 0049; 0053; 0054; 0055; 0056; 0058; 0059; 0060; 0067; 0068; 0069; 0070; 0071; 0072; 0073; 0074; 0075; 0076; 0077; 0078; 0079; 0104; 0105; 0106; 0107; 0108; 0109; 0110; 0111; 0112; 0113; 0114; 0115; 0116; 0117; 0118; 0119; 0125; 0126; 0127; 0128; 0177; 0178; 0179; 0180; 0184; 0185; 0196; 0197; 0198; 0199; 0200; 0201; 0202; 0206; 0207; 0208; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0219; 0220; 0221; 0222; 0223; 0224; 0234; 0247; 0248; 0249; 0250; 0251; 0252; 0253; 0254; 0255; 0256; 0260; 0261; 0262; 0263; 0264; 0269; 0270; 0271; 0272; 0273; 0274; 0275; 0276; 0277; 0278; 0279; 0280; 0281; 0282; 0283; 0284 ASTE-0009; 0010; 0011; 0018; 0019; 0020; 0021; 0022; 0023; 0024; 0025; 0026; 0027; 0028; 0033; 0036; 0037; 0038; 0039; 0040; 0045; 0046; 0047; 0048; 0049; 0050; 0051; 0052; 0053; 0054; 0055; 0061; 0066; 0067; 0068; 0069; 0070; 0071; 0072; 0073; 0074; 0075; 0076; 0081; 0082; 0088; 0089; 0090; 0091; 0092; 0093; 0094; 0095; 0096; 0097; 0098; 0099; 0100; 0101; 0102; 0103; 0104; 0105; 0106; 0107; 0109; 0110; 0111; 0112; 0113; 0114; 0115; 0116; 0117; 0118; 0119; 0120; 0121; 0132; 0133; 0137; 0138; 0139; 0140; 0141; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0149; 0150; 0151; 0156; 0157; 0158; 0159; 0160; 0161; 0162; 0167; 0168; 0169; 0170; 0182; 0183; 0184; 0185; 0186; 0188; 0189; 0190; 0191; 0192; 0193; 0194; 0204; 0205; 0206; 0207; 0208; 0227; 0228; 0229; 0230; 0231; 0232; 0233; 0234; 0235; 0236; 0237; 0238; 0239; 0240; 0241; 0242; 0251; 0252; 0253; 0256; 0257; 0258; 0259; 0260; 0261; 0262; 0263; 0264; 0265; 0266; 0267; 0268; 0269; 0270; 0271; 0272; 0273; 0274; 0275; 0276; 0277; 0283; 0284; 0285; 0286; 0287; 0288; 0289; 0290; 0291; 0292; 0293; 0294; 0295; 0296; 0297; 0298; 0307; 0308; 0309; 0310; 0311; 0312; 0313; 0314; 0315; 0316; 0317; 0323; 0324; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0340; 0341; 0342; 0343; 0344; 0345; 0346; 0347; 0363; 0364; 0365; 0366; 0367; 0368; 0369; 0376 ASTF-0011; 0012; 0013; 0020; 0021; 0022; 0023; 0024; 0025; 0026; 0038; 0039; 0040; 0041; 0042; 0043; 0044; 0045; 0046; 0047; 0056; 0057; 0058; 0059; 0060; 0064; 0065; 0066; 0067; 0068; 0069; 0083; 0084; 0085; 0087; 0088; 0089; 0090; 0091; 0092; 0094; 0095; 0096; 0097; 0098; 0099; 0100; 0101; 0102; 0103; 0104; 0105; 0106; 0107; 0108; 0109; 0114; 0115; 0116; 0117; 0120; 0126; 0127; 0128; 0129; 0130; 0131; 0132; 0133; 0134; 0142; 0143; 0144; 0152; 0153; 0154; 0156; 0157; 0158; 0159; 0160; 0161; 0163; 0164; 0165; 0171; 0172; 0173; 0174; 0175; 0176; 0179; 0180; 0181; 0182; 0183; 0184; 0185; 0186; 0187; 0188; 0189; 0190; 0191; 0192; 0193; 0199; 0200; 0201; 0202; 0203; 0204; 0205; 0206; 0207; 0208; 0209; 0210; 0211; 0212; 0213; 0214; 0215; 0216; 0217; 0218; 0219; 0223; 0224; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0232; 0233; 0234; 0235; 0236; 0237; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245; 0246; 0247; 0248; 0249; 0250; 0251; 0252; 0253; 0254; 0255; 0256; 0257; 0258; 0259; 0260; 0261; 0262; 0263; 0264; 0265; 0266; 0267; 0268; 0269; 0270; 0271; 0272; 0273; 0274; 0275; 0276; 0277; 0278; 0279; 0280; 0281; 0282; 0283; 0284; 0285; 0286; 0287; 0288; 0289; 0290; 0291; 0292; 0293; 0294; 0295; 0296; 0297; 0298; 0299; 0300; 0302; 0303; 0304; 0305; 0306; 0307; 0308; 0309; 0310; 0311; 0312; 0313; 0314; 0315; 0316; 0317; 0318; 0319; 0320; 0321; 0322; 0323; 0324; 0325; 0326; 0327; 0328; 0329; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0340; 0341; 0342; 0343; 0344; 0345; 0346; 0347; 0348; 0349; 0350; 0351; 0352; 0353; 0354; 0355; 0356; 0357; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0366; 0367; 0368; 0369; 0370; 0371; 0372; 0373; 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Draeger Medical, Inc. is recalling Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not appli due to The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation du. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
Recommended Action
Per FDA guidance
On October 15, 2024 Urgent Medical Device Correction letters were sent to customers. Necessary Action: The corrective action is to replace the ventilator motor assembly. You will be contacted by your local Draeger Service Representative to arrange a date for the ventilator motor assembly replacement. Until the corrective action is implemented, you may continue operating your devices with the customary care by only using the device under permanent supervision in line with the Atlan Instructions for Use. If the mechanical ventilation fails, use Man/Spont ventilation mode to ventilate the patient manually as needed. Monitor the patient s condition specifically their oxygenation status as a brief cessation of ventilation can potentially lead to e.g.; hypoxia, loss of lung recruitment, bradycardia and cardiac arrest. If preferred, the alarm priority of the "Ventilator error!!!" can be downgraded with "ALARM RESET" after switching to Man/Spont ventilation mode. Identification of affected medical devices: According to our records, you have received at least one Atlan anesthesia workstation manufactured by Draegerwerk AG & Co. KGaA that may be affected by this issue. Please refer to the attached list of affected serial numbers. Please ensure that all users of the Drger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. Please complete and return the attached Medical Device Correction Return Response Acknowledgment and Receipt Form to confirm that you have received this information. If you have made the products available to third parties, please forward this Urgent Medical Device Correction notice to them. If you have any questions regarding the operation of your Atlan A350/A350XL anesthesia workstation, please contact Draeger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026