FDAFDA · Food and drugs·Recall number Z-0304-2025

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

Published November 20, 2024 · Recall initiated: October 15, 2024

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Draeger Medical, Inc.
Distributor: US Nationwide distribution in the states of AL, AZ, CA, FL, GA, IA, IL, KY, MA, ME, ND, NE, NH, NJ, NY, OH, PA, TN, TX, WI, WY. International distribution: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Columbia, Croatia, Czech Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Malaysia, Mauritius, Mexico, Morocco, Namibia, Nepal, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uruguay, United Arab Emirates, Vietnam.
Lot: 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; 028
Risk classification: Class I
Area (FDA): device
Country: United States

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