Draeger Medical, Inc. recalls Brand Name: Atlan Product Name: Atlan A300 Model/Catalog

Hazard / Issue

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

Issued by

FDA

Distribution: No Atlan A300 or A300XL devices were imported into the US. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Bulgaria, Cambodia, Canada, Chili, China, Colombia, 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, and Vietnam.

Lot/Code Info: Model/Catalog Number: 8211300; UDI-DI Number: 04048675556343; Serial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: ASTA-0314; 0315; 0325; 0338; 0340; 0384; 0411; 0425 ASTB-0002; 0010; 0018; 0151; 0160; 0161; 0165; 0175; 0176; 0177; 0178; 0179; 0180; 0181; 0182; 0214; 0215; 0218; 0232; 0233; 0234; 0235; 0236; 0248; 0249; 0250; 0262; 0263; 0264; 0265; 0266; 0276; 0277; 0278; 0279; 0280 ASTC-0008; 0025; 0036; 0037; 0038; 0039; 0040; 0041; 0042; 0046; 0047; 0048; 0049; 0050; 0062; 0063; 0064; 0077; 0078; 0079; 0080; 0081; 0089; 0090; 0091; 0092; 0093; 0102; 0103; 0104; 0123; 0124; 0125; 0126; 0127; 0133; 0139; 0140; 0150; 0151; 0152; 0153; 0154; 0169; 0176; 0177; 0178; 0179; 0182; 0183; 0184; 0185; 0186; 0187; 0192; 0195; 0196; 0200; 0201; 0202; 0203; 0242 ASTD-0028; 0051; 0052; 0080; 0081; 0082; 0083; 0084; 0085; 0086; 0087 ASTE-0012; 0013; 0014; 0015; 0041; 0042; 0043; 0044; 0063; 0064; 0065; 0084; 0176; 0177; 0178; 0179; 0243; 0244; 0282; 0299 ASTF-0005; 0006; 0019; 0027; 0028; 0029; 0048; 0049; 0050; 0072; 0073; 0074; 0075; 0082; 0093; 0110; 0111; 0162; 0166; 0167; 0197; 0198; 0220; 0221; 0222; 0301; 0406; 0434 ASTH-0001; 0002; 0003; 0024; 0025; 0041; 0042; 0043; 0044; 0097; 0098; 0099; 0115; 0116; 0117; 0118; 0149; 0150; 0151; 0152; 0153; 0195; 0196; 0197; 0198; 0220; 0221; 0222; 0227; 0228; 0229; 0230; 0257; 0258; 0259; 0260; 0261; 0274; 0275; 0276; 0277; 0297; 0298; 0299; 0304; 0305; 0328; 0329; 0355; 0356; 0357; 0393; 0394; 0395; 0396; 0407; 0408; 0409; 0410; 0423; 0424; 0425; 0426; 0427; 0428; 0445; 0446; 0447; 0448; 0449; 0465; 0466; 0467; 0468; 0469; 0470; 0484; 0485; 0486; 0487 ASTK-0033; 0034; 0035; 0062