{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "73333", "product_res_number": "Z-0087-2009", "event_date_initiated": "2008-08-22", "event_date_posted": "2008-10-08", "recall_status": "Terminated", "event_date_terminated": "2009-09-01", "res_event_number": "49442", "product_code": "BSZ", "k_numbers": [ "K042607" ], "product_description": "Draeger Medical Apollo Anesthesia Machine, catalog number 8606500", "code_info": "Catalog number 8606500. Serial numbers ARZC-0142, ARZC-0143, ARZC-0144, ARZC-0145, ARZC-0146, ARZC-0147, ARZC-0148, ARZC-0149, ARZC-0150, ARZC-0151, ARZC-0152, ARZC-0153, ARZC-0172, ARZC-0173, ARZC-0174, ARZC-0175, ARZC-0176, ARZC-0177, ARZC-0192, ARZC-0193,ARZC-0196, ARZC-0197, ARZC-0198, ARZC-0199, ARZC-0200, ARZD-0001, ARZD-0002, ARZD-0003, ARZD-0010, ARZD-0011, ARZD-0012, ARZD-0013, ARZD-0014, ARZD-0015, ARZD-0016, ARZD-0017, ARZD-0018, ARZD-0019, ARZD-0020, ARZD-0021, ARZD-0022, ARZD-0023, ARZD-0024, ARZD-0025, ARZD-0026, ARZD-0027, ARZD-0028, ARZD-0029, ARZD-0030, ARZD-0031, ARZD-0032, ARZD-0033, ARZD-0034, ARZD-0035, ARZD-0036, ARZD-0037, ARZD-0038, ARZD-0039, ARZD-0040, ARZD-0041, ARZD-0042, ARZD-0043, ARZD-0044, ARZD-0058, ARZD-0059, ARZD-0060, ARZD-0061, ARZD-0062, ARZD-0063, ARZD-0064, ARZD-0065, ARZD-0066, ARZD-0067, ARZD-0068, ARZD-0069, ARZD-0070, ARZD-0071, ARZD-0072, ARZD-0073, ARZD-0074, ARZD-0075, ARZD-0076, ARZD-0077, ARZD-0078, ARZD-0079, ARZD-0080, ARZD-0081, ARZD-0082, ARZD-0083, ARZD-0084, ARZD-0085, ARZD-0086, ARZD-0087, ARZD-0117, ARZD-0118, ARZD-0119, ARZD-0120, ARZD-0121, ARZD-0122, ARZD-0125, ARZD-0126, ARZD-0127, ARZD-0128, ARZD-0129, ARZD-0130, ARZD-0131, ARZD-0132, ARZD-0133, ARZD-0134, ARZD-0135, ARZD-0136, ARZD-0183, ARZD-0184, ARZD-0185, ARZD-0186, ARZD-0187, ARZD-0188, ARZD-0189, ARZD-0190, ARZD-0191, ARZD-0192, ARZD-0193, ARZD-0194, ARZD-0195, ARZD-0196, ARZD-0197, ARZD-0198, ARZD-0199, ARZD-0200, ARZD-0201, ARZD-0202, ARZD-0203, ARZD-0255, ARZD-0256, ARZD-0257, ARZD-0258, ARZD-0259, ARZD-0260, ARZD-0261, ARZD-0262, ARZD-0263, ARZD-0264, ARZD-0265, ARZD-0266, ARZD-0267, ARZD-0268, ARZD-0269, ARZD-0270, ARZD-0271, ARZE-0001, ARZE-0002, ARZE-0003, ARZE-0004, ARZE-0005, ARZE-0008, ARZE-0009, ARZE-0010, ARZE-0023, ARZE-0024, ARZE-0025, ARZE-0026, ARZE-0027, ARZE-0028, ARZE-0029, ARZE-0030, ARZE-0059, ARZE-0060, ARZE-0061, ARZE-0062, ARZE-0063, ARZE-0064, ARZE-0065, ARZE-0115, ARZE-0116, ARZE-0173, ARZE-0174, ARZE-0175, ARZE-0176, ARZE-0189, ARZE-0190, ARZE-0191, ARZE-0192, ARZE-0193, ARZE-0194, ARZE-0195, ARZE-0196, ARZE-0197, ARZE-0198, ARZE-0199, ARZE-0200, ARZE-0201, ARZE-0202, ARZE-0203, ARZE-0204, ARZE-0214, ARZE-0215, ARZE-0216, ARZF-0011, ARZF-0012, ARZF-0013, ARZF-0014, ARZF-0015, ARZF-0016, ARZF-0017, ARZF-0018, ARZF-0019, ARZF-0020, ARZF-0021, ARZF-0022, ARZF-0023, ARZF-0024, ARZF-0025, ARZF-0026, ARZF-0027, ARZF-0028, ARZF-0029, ARZF-0030, ARZF-0031, ARZF-0084, ARZF-0087, ARZF-0088, ARZF-0089, ARZF-0090, ARZF-0091, ARZF-0092, ARZF-0093, ARZF-0094, ARZF-0095, ARZF-0096, ARZF-0097, ARZF-0098, ARZF-0099, ARZF-0100, ARZF-0101, ARZF-0102, ARZF-0103, ARZF-0104, ARZF-0105, ARZF-0106, ARZF-0107, ARZF-0108, ARZF-0109, ARZF-0110, and ARZF-0111.", "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": "Technical Support\n800-543-5047", "reason_for_recall": "Sporadic errors in various device functions, including low readings of the single gas flows for oxygen, nitrous oxide, or air delivery, or mechanical ventilation failure. Alarms and error messages function as designed.", "root_cause_description": "Nonconforming Material/Component", "action": "Draeger Medical sent a Medical Device Recall letter to their customers via certified mail on 8/22/08 informing them of the problem. Until the exchange of affected printed circuit boards has been implemented, the firm is recommending that users closely monitor all device displays and error messages and if applicable act in accordance with the advisory statements and remedial information provided in the Instructions for Use as well as making provisions for alternative patient care measures.", "product_quantity": "214 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K123211", "K800801", "K893780", "K102182", "K844849", "K160665", "K033026", "K844012", "K771989", "K151570", "K890410", "K042086", "K844421", "K830680", "K103035", "K092864", "K830159", "K864589", "K003579", "K863207", "K071097", "K010613", "K102471", "K122063", "K083098", "K131790", "K771057", "K172045", "K963994", "K844008", "K051629", "K872178", "K861170", "K900937", "K171311", "K081447", "K981530", "K253330", "K973896", "K913791", "K001988", "K862085", "K083413", "K170872", "K864806", "K945234", "K830161", "K903135", "K123125", "K884879", "K072420", "K032803", "K925580", "K852175", "K993410", "K945463", "K923519", "K864644", "K122445", "K142552", "K853139", "K921742", "K946127", "K791530", "K113633", "K062155", "K770554", "K000706", "K853435", "K042607", "K971030", "K945722", "K001315", "K071142", "K801102", "K884802", "K830160", "K771479", "K251352", "K963481", "K050883", "K011404", "K983635", "K930492", "K833147", "K062388", "K132530", "K833151", "K050676", "K901119", "K982137", "K252746", "K052335", "K850648", "K980553", "K974193", "K090892", "K802591", "K973971", "K143530", "K930351", "K140264", "K884991", "K031400", "K041430", "K090233", "K973985", "K822218", "K120075", "K191027", "K001727", "K970163", "K862831", "K042419", "K201957", "K902962", "K151954", "K920944", "K934669", "K875350", "K022031", "K171292", "K935546", "K833335", "K854213", "K133958", "K903991", "K061102", "K042154", "K981845", "K882489", "K133886", "K073707", "K131945", "K230931", "K101439", "K905635", "K840356", "K803052", "K864590", "K790456", "K992421", "K061609", "K844563", "K965041", "K112114", "K000859", "K801103", "K081844", "K112722", "K001488", "K050626", "K841274", "K781492", "K132903", "K973949", "K030939", "K050055", "K901713", "K864447", "K012446", "K965160", "K040743", "K213867", "K901117", "K060193", "K000995", "K760228", "K102389", "K900328", "K894309", "K971425", "K003663", "K030624", "K080175", "K851621", "K033498", "K841370", "K041622", "K801100", "K855022", "K072884", "K003251", "K933285", "K972848", "K081941", "K110213", "K923172", "K900329" ], "registration_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "9611500", "3007238566", "3001104093", "3021559257", "1000122786", "1054713", "9611295", "3016618143", "3014579161", "3007603826", "1066270", "1066427", "8043316", "3022543477", "9617604", "3000126629", "2221819", "3009129579", "9610531", "3009156722", "2112667", "3010157426", "3005783425", "8010042", "9710602", "3003589956", "1530958", "3035111606" ], "fei_number": [ "", "3005803793", "2518157", "3010703925", "2020813", "3013188547", "3007238566", "3001104093", "3021559257", "1000122786", "1000639866", "3007513035", "1000114111", "3016618143", "3014579161", "3007603826", "3023530182", "3002558692", "3003319165", "3022543477", "3002808128", "3000126629", "3002807992", "3009129579", "2221819", "3009156722", "2112667", "3000957797", "3010157426", "3002807907", "3005783425", "3003513129", "3003589956", "3035111606" ], "device_name": "Gas-Machine, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5160", "device_class": "2" } } ] }