Draeger Medical, Inc.: Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

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.

Details from the source

Reason for recall: The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use. Distribution: 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, Quantity: 1,492 units (139 units US, 1,353 OUS) Lot/code info: 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;

UPC codes

04048675556176

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.