Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

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

Code information: Model/Catalog Number: 8621600; UDI-DI Number: 04048675556183; Serial Numbers Distributed in the US: ASTA-0307; 0309; 0311; 0349; 0350; 0351; 0353; 0363; 0365; 0394; 0408; 0409 ASTB-0048; 0286; 0287; 0288; 0289; 0290; 0291; 0304; 0305; 0306; 0307; 0308; 0309; 0317; 0318; 0319; 0320; 0321; 0322 ASTC-0006; 0007; 0068; 0069; 0070; 0082; 0083; 0099; 0100; 0101; 0105; 0106; 0107; 0108; 0109; 0118; 0119; 0136; 0137; 0229; 0230; 0243; 0244; 0245 ASTD-0008; 0009; 0010; 0011; 0012; 0013; 0014; 0129; 0130; 0131; 0132; 0133; 0134; 0135; 0154; 0159; 0160; 0161; 0162; 0163; 0164; 0165; 0166; 0167; 0168; 0169; 0181; 0182; 0183; 0193; 0194; 0195; 0225; 0226; 0227; 0228; 0229; 0230; 0231; 0238; 0239; 0240; 0241; 0242; 0243; 0244; 0245 ASTE-0016; 0017; 0077; 0078; 0079; 0086; 0087; 0122; 0123; 0124; 0125; 0126; 0129; 0130; 0131; 0163; 0164; 0165; 0166; 0171; 0172; 0173; 0174; 0195; 0196; 0197; 0198; 0203; 0225; 0226; 0246; 0247; 0248; 0249; 0250; 0278; 0279; 0280; 0281; 0301; 0302; 0303; 0304; 0305; 0306; 0348; 0349; 0350; 0351; 0352; 0357; 0358; 0359; 0360; 0361; 0362 ASTF-0001; 0002; 0003; 0004; 0014; 0015; 0016; 0017; 0018; 0030; 0031; 0032; 0033; 0034; 0035; 0036; 0037; 0055; 0061; 0062; 0063; 0070; 0071; 0076; 0077; 0078; 0079; 0080; 0081; 0121; 0122; 0123; 0124; 0125; 0135; 0136; 0137; 0138; 0139; 0140; 0141; 0168; 0169; 0170; 0194; 0195; 0196; 0409; 0410; 0411; 0436; 0437; 0438; 0474; 0475; 0476; 0477; 0478 ASTH-0007; 0008; 0009; 0010; 0011; 0012; 0092; 0093; 0094; 0095; 0096; 0120; 0121; 0122; 0123; 0124; 0125; 0126; 0142; 0143; 0144; 0145; 0146; 0147; 0148; 0169; 0170; 0171; 0172; 0173; 0174; 0175; 0187; 0188; 0189; 0190; 0191; 0192; 0269; 0270; 0271; 0272; 0273; 0293; 0294; 0295; 0296; 0306; 0307; 0308; 0309; 0310; 0311; 0324; 0325; 0326; 0327; 0330; 0331; 0332; 0333; 0334; 0335; 0336; 0337; 0338; 0339; 0358; 0359; 0360; 0361; 0362; 0363; 0364; 0365; 0383; 0384; 0385; 0386; 0387; 0388; 0389; 0390; 0450; 0476; 0477; 0478; 0479; 0480; 0481; 0488; 0489; 0490; 0491 Serial Numbers Distributed OUS: ASTA-0253; 0289; 0290; 0327; 0362; 0404; 0405; 0426; 0427; 0428; 0429; 0430 ASTB-0003; 0005; 0007; 0028; 0029; 0030; 0031; 0032; 0033; 0075; 0076; 0077; 0079; 0080; 0081; 0082; 0083; 0084; 0134; 0195; 0206; 0219; 0220; 0237 ASTC-0001; 0002; 0003; 0004; 0026; 0138; 0163; 0180; 0181; 0194; ASTD-0015; 0016; 0050; 0061; 0062; 0063; 0064; 0065; 0066; 0203; 0204; 0205; 0265; 0266; 0267 ASTE-0034; 0035; 0057; 0058; 0059; 0060; 0062; 0085; 0108; 0127; 0128; 0175; 0202; 0223; 0224; 0300; 0325; 0326; 0327; 0328; 0329; 0353; 0354; 0355; 0356 ASTF-0051; 0052; 0053; 0054; 0112; 0113; 0435; 0471 ASTH-0039; 0040; 0045; 0046; 0081; 0082; 0176; 0193; 0194; 0204; 0217; 0218; 0219; 0225; 0226; 0243; 0244; 0245; 0246; 0255; 0256; 0382; 0403; 0404; 0405; 0406; 0434; 0435; 0436; 0437; 0451; 0452; 0453; 0 ASTJ-0063; 0064; 0065; 0066; 0067; 0068; 0089; 0090; 0091; 0092; 0145; 0146; 0147; 0171; 0237 ASTK-0002

Distribution pattern: 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.