{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "215847", "product_res_number": "Z-2616-2025", "event_date_initiated": "2025-09-09", "event_date_posted": "2025-10-01", "recall_status": "Open, Classified", "res_event_number": "97525", "product_code": "BSZ", "k_numbers": [ "K230931" ], "product_description": "Brand Name: Atlan\nProduct Name: Atlan A350\nModel/Catalog Number: 8211500\nSoftware Version: Not applicable\nProduct Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions\nComponent: Not applicable", "code_info": "Lot Code: UDI-DI Number: 04048675556176\nSerial Numbers Distributed in the US:\nASTB-0181\nASTC-0005,ASTC-0006,ASTC-0007\nASTD-0244,ASTD-0259\nASTE-0180,ASTE-0254,ASTE-0255 \nASTH-0083,ASTH-0464\nASUA-0479,ASUA-0482\nASUB-0012,ASUB-0013,ASUB-0015,ASUB-0017,ASUB-0018,ASUB-0292\nASUC-0065,ASUC-0084,ASUC-0085,ASUC-0086,ASUC-0087,ASUC-0088,ASUC-0090,ASUC-0091,\nASUC-0092,ASUC-0096,ASUC-0097,ASUC-0099,ASUC-0100,ASUC-0101,ASUC-0102,ASUC-0103,\nASUC-0104,ASUC-0105,ASUC-0107,ASUC-0108,ASUC-0109,ASUC-0110,ASUC-0111,ASUC-0112,\nASUC-0113,ASUC-0116,ASUC-0117,ASUC-0118,ASUC-0119,ASUC-0120,ASUC-0121,ASUC-0122,\nASUC-0123,ASUC-0125,ASUC-0126,ASUC-0127,ASUC-0128,ASUC-0129,ASUC-0130,ASUC-0131,\nASUC-0132,ASUC-0133,ASUC-0134,ASUC-0135,ASUC-0136,ASUC-0137,ASUC-0138,ASUC-0139,\nASUC-0140,ASUC-0141,ASUC-0142,ASUC-0143,ASUC-0143,ASUC-0144,ASUC-0145,ASUC-0162,\nASUC-0163,ASUC-0164,ASUC-0165,ASUC-0166,ASUC-0167,ASUC-0168,ASUC-0169,ASUC-0170,\nASUC-0171,ASUC-0172,ASUC-0173,ASUC-0203,ASUC-0204,ASUC-0205,ASUC-0206,ASUC-0207,\nASUC-0208,ASUC-0209,ASUC-0210,ASUC-0218,ASUC-0219,ASUC-0220,ASUC-0221,ASUC-0222,\nASUC-0223,ASUC-0224,ASUC-0225,ASUC-0235,ASUC-0236,ASUC-0237,ASUC-0340,ASUC-0341\nASUD-0244,ASUD-0261,ASUD-0262,ASUD-0263,ASUD-0267,ASUD-0281,ASUD-0282,ASUD-0283\n\nSerial Numbers Distributed OUS\nASUA-0353,ASUA-0441,ASUA-0447,ASUA-0472,ASUA-0478,ASUA-0496,,SUA-0497,ASUA-0500,\nASUB-0004,ASUB-0024,ASUB-0025,ASUB-0030,ASUB-0033,ASUB-0034,ASUB-0035,ASUB-0038,\nASUB-0039,ASUB-0040,ASUB-0041,ASUB-0043,ASUB-0044,ASUB-0046,ASUB-0048,ASUB-0063,\nASUB-0064,ASUB-0066,ASUB-0067,ASUB-0069,ASUB-0073,ASUB-0074,ASUB-0075,ASUB-0076,\nASUB-0077,ASUB-0095,ASUB-0096,ASUB-0097,ASUB-0098,ASUB-0099,ASUB-0100,ASUB-0101,\nASUB-0102,ASUB-0104,ASUB-0105,ASUB-0107,ASUB-0108,ASUB-0109,ASUB-0112,ASUB-0113,\nASUB-0114,ASUB-0115,ASUB-0116,ASUB-0118,ASUB-0120,ASUB-0121,ASUB-0122,ASUB-0123,\nASUB-0124,ASUB-0128,ASUB-0129,ASUB-0130,ASUB-0136,ASUB-0137,ASUB-0139,ASUB-0140,\nASUB-0141,ASUB-0143,ASUB-0144,ASUB-0145,ASUB-0146,ASUB-0147,ASUB-0148,ASUB-0149,\nASUB-0150,ASUB-0151,ASUB-0152,ASUB-0153,ASUB-0154,ASUB-0155,ASUB-0156,ASUB-0157,\nASUB-0158,ASUB-0159,ASUB-0160,ASUB-0161,ASUB-0162,ASUB-0163,ASUB-0177,ASUB-0178,\nASUB-0188,ASUB-0189,ASUB-0190,ASUB-0191,ASUB-0192,ASUB-0193,ASUB-0194,ASUB-0195,\nASUB-0196,ASUB-0197,ASUB-0198,ASUB-0199,ASUB-0201,ASUB-0202,ASUB-0203,ASUB-0204,\nASUB-0205,ASUB-0206,ASUB-0207,ASUB-0208,ASUB-0209,ASUB-0210,ASUB-0211,ASUB-0223,\nASUB-0224,ASUB-0225,ASUB-0226,ASUB-0227,ASUB-0229,ASUB-0230,ASUB-0231,ASUB-0232,\nASUB-0233,ASUB-0234,ASUB-0235,ASUB-0236,ASUB-0237,ASUB-0238,ASUB-0240,ASUB-0243,\nASUB-0245,ASUB-0252,ASUB-0253,ASUB-0254,ASUB-0255,ASUB-0256,ASUB-0257,ASUB-0258,\nASUB-0260,ASUB-0261,ASUB-0262,ASUB-0263,ASUB-0264,ASUB-0265,ASUB-0271,ASUB-0272,\nASUB-0273,ASUB-0276,ASUB-0278,ASUC-0001ASUC-0004,ASUC-0016,ASUC-0017,ASUC-0018,\nASUC-0019,ASUC-0020,ASUC-0022,ASUC-0024,ASUC-0026,,ASUC-0028,,ASUC-0030,ASUC-0031,\nASUC-0032,ASUC-0033,ASUC-0034,ASUC-0035,ASUC-0036,ASUC-0039,ASUC-0061,ASUC-0062,\nASUC-0063,ASUC-0226,ASUC-0227,ASUC-0228,ASUC-0229,ASUC-0230,ASUC-0232,ASUC-0233,\nASUC-0234,ASUC-0247,ASUC-0248,ASUC-0249,ASUC-0250,ASUC-0251,ASUC-0252,ASUC-0253,\nASUC-0254,ASUC-0255,ASUC-0256,ASUC-0257,ASUC-0262,ASUC-0263,ASUC-0264,ASUC-0265,\nASUC-0266,ASUC-0267,ASUC-0269,ASUC-0272,ASUC-0273,ASUC-0274,ASUC-0275,ASUC-0276,\nASUC-0277,ASUC-0278,ASUC-0279,ASUC-0284,ASUC-0286,ASUC-0287,ASUC-0288,ASUC-0289,\nASUC-0290,ASUC-0291,ASUC-0292,ASUC-0293,ASUC-0294,ASUC-0295,ASUC-0296,ASUC-0300,\nASUC-0301,ASUC-0302,ASUC-0303,ASUC-0304,ASUC-0305,ASUC-0306ASUC-0307,ASUC-0308,\nASUC-0309,ASUC-0310,ASUC-0311,ASUC-0314,ASUC-0315,ASUC-0316,ASUC-0319,ASUC-0320,\nASUC-0321,ASUC-0322,ASUC-0323,ASUC-0339,ASUC-0342,ASUC-0343,ASUC-0344,ASUC-0345,\nASUC-0346,ASUC-0348,ASUC-0349,ASUC-0350,ASUC-0351,ASUC-0352,ASUC-0353,ASUC-0354,\nASUC-0355,ASUC-0356,ASUC-0357,ASUC-0358,ASUC-0359,ASUC-0360,ASUC-0361,ASUC-0362,\nASUC-0363,ASUC-0364,ASUC-0365,ASUC-0366,ASUC-0367,ASUC-0380,ASUC-0381,ASUC-0382,\nASUC-0383,ASUC-0384,ASUC-0385,ASUC-0386,ASUC-0387,ASUC-0391,ASUC-0392,ASUC-0393,\nASUC-0394,ASUC-0395,ASUC-0396,ASUC-0397,ASUC-0398,ASUC-0399,ASUC-0400,ASUC-0401,\nASUC-0402,ASUC-0403,ASUC-0404,ASUC-0405,ASUC-0406,ASUC-0407,ASUC-0408,ASUC-0409,\nASUC-0410,ASUC-0416,ASUD-0001,ASUD-0002,ASUD-0004,ASUD-0005,ASUD-0006,ASUD-0007,\nASUD-0008,ASUD-0009,ASUD-0010,ASUD-0011,ASUD-0012,ASUD-0013,ASUD-0014,ASUD-0015,\nASUD-0016,ASUD-0018,ASUD-0019,ASUD-0020,ASUD-0022,ASUD-0023,ASUD-0041,ASUD-0042,\nASUD-0043,ASUD-0044,ASUD-0046,ASUD-0047,ASUD-0048,ASUD-0049,ASUD-0050,ASUD-0051,\nASUD-0057,ASUD-0059,ASUD-0060,ASUD-0061,ASUD-0062,ASUD-0063,ASUD-0064,ASUD-0065,\nASUD-0066,ASUD-0074,ASUD-0075,ASUD-0077,ASUD-0078,ASUD-0079,ASUD-0080,ASUD-0081,\nASUD-0098,ASUD-0099,ASUD-0100,ASUD-0101,ASUD-0102,ASUD-0103,ASUD-0104,ASUD-0105,\nASUD-0106,ASUD-0107,ASUD-0108,ASUD-0109,ASUD-0126,ASUD-0127,ASUD-0128,ASUD-0129,\nASUD-0130,ASUD-0131,ASUD-0133,ASUD-0135,ASUD-0136,ASUD-0140,ASUD-0141,ASUD-0150,\nASUD-0168,ASUD-0173,ASUD-0174,ASUD-0175,ASUD-0181,ASUD-0182,ASUD-0183,ASUD-0184,\nASUD-0185,ASUD-0186,ASUD-0196,ASUD-0198,ASUD-0199,ASUD-0200,ASUD-0201,ASUD-0202,\nASUD-0203,ASUD-0204,ASUD-0205,ASUD-0206,ASUD-0219,ASUD-0220,ASUD-0221,ASUD-0222,\nASUD-0223,ASUD-0224,ASUD-0225,ASUD-0226,ASUD-0227,ASUD-0228,ASUD-0238,ASUD-0239,\nASUD-0245,ASUD-0246,ASUD-0247,ASUD-0248,ASUD-0249,ASUD-0250,ASUD-0251,ASUD-0252,\nASUD-0253,ASUD-0258,ASUD-0259,ASUD-0260,ASUD-0273,ASUD-0274", "firm_fei_number": "2517967", "recalling_firm": "Draeger, 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 device 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 09/09/2025, \"URGENT MEDICAL DEVICE CORRECTION\" letters were sent to customers.\nActions to be taken:\n- The corrective action is for a Drger Service Representative to inspect, and, if necessary, replace the ventilator motor\nassembly. You will be contacted by your local Drger Service Representative to arrange a date for the ventilator\nmotor assembly inspection and, if necessary, replacement.\n- Please ensure that all users of the Drger Atlan as well as other persons concerned within your organization are made\naware of this Urgent Medical Device Correction notice.\n- Please complete and return the attached Medical Device\nCorrection Return Response Acknowledgment and Receipt Form to confirm that you have received this information.\n- If you have made the products available to third parties, please forward this Urgent Medical Device Correction notice\nto them.\nIf you have any questions regarding the operation of your Atlan A350/A350XL anesthesia workstation, please contact\nDrger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the\nprompt, then 2, then 2 again).\nIf you have any questions regarding this Urgent Medical Device Correction notice, please contact Michael\nKelhart between the hours of 8:00 AM 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com.\nAdverse events or quality problems experienced with the use of this product may be reported to FDA s MedWatch\nAdverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by phone at 1-800-FDA-1088.", "product_quantity": "530", "distribution_pattern": "Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries:\nArgentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.", "openfda": { "k_number": [ "K001988", "K935546", "K131790", "K900328", "K864447", "K090233", "K894309", "K113633", "K851621", "K112722", "K900329", "K122063", "K771989", "K840356", "K841370", "K251352", "K143530", "K901117", "K830159", "K875350", "K031400", "K102182", "K850648", "K882489", "K963481", "K790456", "K081844", "K062155", "K981845", "K791530", "K980553", "K945722", "K033498", "K844421", "K060193", "K101439", "K971425", "K972848", "K862085", "K983635", "K123211", "K864806", "K151570", "K760228", "K923172", "K945234", "K855022", "K120075", "K050883", "K973985", "K071097", "K965160", "K822218", "K042154", "K872178", "K030624", "K160665", "K890410", "K803052", "K172045", "K201957", "K920944", "K081447", "K801103", "K982137", "K030939", "K833335", "K862831", "K900937", "K884879", "K050055", "K830160", "K946127", "K052335", "K853435", "K170872", "K973896", "K041622", "K010613", "K061609", "K841274", "K073707", "K933285", "K132903", "K213867", "K102471", "K003251", "K852175", "K781492", "K884802", "K253330", "K921742", "K973949", "K000706", "K171292", "K081941", "K131945", "K072884", "K974193", "K103035", "K252746", "K042607", "K003579", "K032803", "K000859", "K833147", "K864644", "K902962", "K925580", "K151954", "K230931", "K854213", "K191027", "K771057", "K122445", "K771479", "K123125", "K140264", "K981530", "K770554", "K011404", "K802591", "K083413", "K903135", "K061102", "K973971", "K833151", "K934669", "K905635", "K800801", "K022031", "K801100", "K913791", "K923519", "K993410", "K133886", "K830680", "K844012", "K012446", "K080175", "K042419", "K083098", "K050626", "K844008", "K092864", "K930351", "K930492", "K971030", "K142552", "K001727", "K863207", "K033026", "K040743", "K970163", "K963994", "K041430", "K062388", "K830161", "K042086", "K050676", "K003663", "K861170", "K945463", "K893780", "K090892", "K853139", "K864590", "K132530", "K102389", "K901713", "K072420", "K965041", "K844563", "K801102", "K903991", "K844849", "K901119", "K001488", "K000995", "K001315", "K884991", "K071142", "K051629", "K864589", "K110213", "K112114", "K133958", "K171311", "K992421" ], "registration_number": [ "", "3001104093", "1530958", "3005783425", "1054713", "3009156722", "3010157426", "2020813", "3003589956", "8010042", "9710602", "1066270", "2518157", "3016618143", "9611500", "3021559257", "1000122786", "3010703925", "3014579161", "2221819", "9617604", "9611295", "3000126629", "3022543477", "8043316", "3035111606", "3007238566", "3013188547", "3009129579", "1066427", "3005803793", "3007603826", "2112667", "9610531" ], "fei_number": [ "", "3001104093", "3000957797", "3005783425", "3002808128", "3009156722", "3010157426", "3002807907", "3002807992", "2020813", "3003589956", "1000639866", "2518157", "3016618143", "3021559257", "3002558692", "1000122786", "3010703925", "3014579161", "1000114111", "2221819", "3003513129", "3000126629", "3007513035", "3022543477", "3035111606", "3023530182", "3007238566", "3013188547", "3003319165", "3009129579", "3005803793", "3007603826", "2112667" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }