{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211121", "product_res_number": "Z-0667-2025", "event_date_initiated": "2024-10-15", "event_date_posted": "2024-12-18", "recall_status": "Open, Classified", "res_event_number": "95759", "product_code": "BSZ", "k_numbers": [ "K230931" ], "product_description": "Brand Name: Atlan \nProduct Name: Atlan A300 \nModel/Catalog Number: 8211300 \n\nThe Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.", "code_info": "Model/Catalog Number: 8211300;\nUDI-DI Number: 04048675556343;\nSerial Numbers shipped directly from Draegerwerk AG & Co., KGaA to OUS: \nASTA-0314; 0315; 0325; 0338; 0340; 0384; 0411; 0425\nASTB-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\nASTC-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\nASTD-0028; 0051; 0052; 0080; 0081; 0082; 0083; 0084; 0085; 0086; 0087\nASTE-0012; 0013; 0014; 0015; 0041; 0042; 0043; 0044; 0063; 0064; 0065; 0084; 0176; 0177; 0178; 0179; 0243; 0244; 0282; 0299\nASTF-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\nASTH-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\nASTK-0033; 0034; 0035; 0062", "firm_fei_number": "2517967", "recalling_firm": "Draeger Medical, Inc.", "address_1": "3135 Quarry Rd", "city": "Telford", "state": "PA", "postal_code": "18969-1042", "additional_info_contact": "Michael Kelhart\n01-267-6641131", "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.", "root_cause_description": "Process control", "action": "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. Please ensure that all users of the Draeger Atlan as well as other persons concerned within your organization are made aware of this Urgent Medical Device Correction notice. Complete and return the 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 8AM-8PM EST at 1-800-437-2437 (press 2, then 2, then 2 again). Questions regarding this Urgent Medical Device Correction notice, contact Michael Kelhart 8AM-4:30PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com.", "product_quantity": "280 units (OUS only)", "distribution_pattern": "No Atlan A300 or A300XL devices were imported into the US.\nDevices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries:\nArgentina, 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.", "openfda": { "k_number": [ "K802591", "K791530", "K112722", "K923172", "K213867", "K981530", "K030939", "K930351", "K850648", "K010613", "K072420", "K151570", "K781492", "K884802", "K071142", "K050055", "K003663", "K132530", "K884879", "K090892", "K864644", "K801100", "K971425", "K131790", "K041430", "K062155", "K072884", "K890410", "K102389", "K083413", "K170872", "K000859", "K102471", "K801103", "K900328", "K855022", "K133958", "K844849", "K872178", "K972848", "K905635", "K771479", "K011404", "K061102", "K001727", "K925580", "K982137", "K042154", "K882489", "K041622", "K000706", "K862085", "K930492", "K830159", "K833147", "K800801", "K003251", "K081844", "K230931", "K980553", "K840356", "K201957", "K060193", "K030624", "K050883", "K971030", "K853435", "K050676", "K131945", "K900937", "K864806", "K801102", "K854213", "K790456", "K973949", "K862831", "K965041", "K963481", "K071097", "K771989", "K945722", "K822218", "K852175", "K875350", "K120075", "K171292", "K945234", "K833335", "K073707", "K101439", "K033498", "K103035", "K191027", "K081447", "K920944", "K973971", "K853139", "K973985", "K894309", "K251352", "K992421", "K760228", "K861170", "K963994", "K830161", "K946127", "K051629", "K001988", "K143530", "K844563", "K012446", "K171311", "K901117", "K133886", "K123125", "K080175", "K903991", "K140264", "K864589", "K081941", "K841274", "K900329", "K122063", "K983635", "K921742", "K031400", "K935546", "K042086", "K901119", "K974193", "K934669", "K122445", "K001488", "K040743", "K803052", "K844421", "K902962", "K003579", "K863207", "K052335", "K970163", "K933285", "K923519", "K771057", "K172045", "K042419", "K062388", "K841370", "K132903", "K903135", "K893780", "K102182", "K112114", "K945463", "K830160", "K001315", "K110213", "K032803", "K864447", "K973896", "K160665", "K965160", "K830680", "K113633", "K090233", "K844012", "K913791", "K083098", "K092864", "K142552", "K993410", "K151954", "K123211", "K033026", "K901713", "K981845", "K022031", "K050626", "K844008", "K864590", "K061609", "K833151", "K770554", "K884991", "K000995", "K252746", "K851621", "K042607", "K253330" ], "registration_number": [ "", "3009156722", "3007238566", "9610531", "1066270", "9611500", "3005783425", "3013188547", "9611295", "3000126629", "3001104093", "2518157", "1000122786", "3003589956", "8043316", "3007603826", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "9617604", "1066427", "3014579161", "8010042", "3010157426", "3009129579", "1530958", "3021559257", "2221819", "9710602", "3016618143", "3010703925", "1054713" ], "fei_number": [ "", "3009156722", "3007238566", "3003513129", "3000957797", "1000114111", "3005783425", "3013188547", "3003319165", "3000126629", "3023530182", "3001104093", "2518157", "1000122786", "3002807907", "3003589956", "3002807992", "3007603826", "3007513035", "3002558692", "3035111606", "3005803793", "2112667", "3022543477", "2020813", "3002808128", "3014579161", "3010157426", "3009129579", "3021559257", "2221819", "1000639866", "3016618143", "3010703925" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }