{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "142643", "product_res_number": "Z-0692-2016", "event_date_initiated": "2015-12-22", "event_date_posted": "2016-02-03", "recall_status": "Terminated", "event_date_terminated": "2017-04-05", "res_event_number": "72914", "product_code": "CBK", "k_numbers": [ "K062267", "K082600", "K103625" ], "product_description": "Emergency Transport Ventilator\nOxylog 3000 Ventilator and Oxylog 3000 plus Ventilator\nCatalog Numbers: 2M86300/2M86965 and 5704813/5704831.\n\nVolume controlled and pressure-controlled emergency and transport ventilators.", "code_info": "All Oxylog 3000 Ventilators and Oxylog 3000 Plus Ventilators with the identified catalog numbers distributed between April 2007 - December 2015.", "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": "215-721-5400", "reason_for_recall": "Drager became aware of situations where the error message \"Poti unplugged\" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.", "root_cause_description": "Device Design", "action": "The firm, Draeger Medical, Inc., sent an \"Urgent Medical Device Recall\" letter dated 12/21/2015 and a copy of the Instructions for Use (IFU) Supplement to consignees in a method that confirms delivery. The letter described the product, problem and actions to be taken. The consignees were instructed to include a copy of the supplement with their Oxylog IFU; inform all affected users in their facility; and contact Draeger Customer Support at 1-800-543-5047 (press 4 at the prompt) to obtain additional copies of the IFU Supplement Free of Charge.\n\nIf there are any questions regarding this letter, please contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger Oxylog ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).\n\nOn 12/09/2016, Draeger mailed an Urgent Medical Device Recall notification letter to affected customers to inform them of a revised new software for the Oxlog 3000/3000plus (version 1.06 for Oxylog 3000 plus and version 1.23 for Oxylog 3000) that reduces the impact of the error condition. Customers will be contacted by a Drager Service Representative to schedule a time to perform the software update free of charge. The new software changes the device behavior in the event of the error (a controller failure). With the new software, in the event of a controller failure, ventilation will not stop. The device will continue to ventilate with the last setting. An alarm will annunciate and be displayed, alerting the user of the controller failure.", "product_quantity": "402 units (314 - Oxylog 3000; 88 - Oxylog 3000 Plus)", "distribution_pattern": "Nationwide Distribution -- including states of AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY.", "openfda": { "k_number": [ "K960168", "K953238", "K193056", "K052554", "K081743", "K111595", "K943412", "K982132", "K864379", "K981971", "K812953", "K051262", "K082351", "K241135", "K980642", "K151814", "K072412", "K081837", "K240807", "K061627", "K123149", "K874371", "K070513", "K053502", "K012693", "K040221", "K981412", "K981072", "K895779", "K013642", "K913423", "K833786", "K974176", "K781926", "K893043", "K790199", "K913972", "K062710", "K010608", "K202970", "K152068", "K881420", "K882764", "K822103", "K842876", "K905235", "K921387", "K002686", "K841818", "K832700", "K241520", "K854300", "K844350", "K864129", "K820248", "K915488", "K083050", "K870275", "K062267", "K822233", "K023350", "K092135", "K871448", "K082966", "K120726", "K130178", "K860798", "K896269", "K972248", "K213098", "K900745", "K893622", "K010317", "K041775", "K822040", "K912619", "K030780", "K871398", "K853760", "K924043", "K024344", "K920002", "K840865", "K112754", "K832467", "K232365", "K925262", "K111146", "K051222", "K942938", "K903089", "K905244", "K964540", "K232836", "K070899", "K884793", "K830488", "K243767", "K960010", "K151252", "K892886", "K901785", "K802051", "K922477", "K051263", "K812961", "K153046", "K012177", "K023135", "K871433", "K792456", "K821930", "K950853", "K820132", "K830230", "K792455", "K771039", "K222024", "K813254", "K871985", "K853300", "K992670", "K781160", "K960964", "K251888", "K093632", "K883809", "K851509", "K060647", "K133868", "K101850", "K953228", "K111683", "K101129", "K933262", "K180295", "K791033", "K822456", "K801890", "K915312", "K922654", "K880721", "K992608", "K813253", "K930747", "K103803", "K792459", "K071194", "K922705", "K981371", "K841393", "K102054", "K030341", "K091238", "K871009", "K093094", "K003068", "K844590", "K073694", "K990429", "K072450", "K010093", "K842362", "K043085", "K862212", "K034040", "K862712", "K853501", "K920121", "K040790", "K201658", "K905272", "K893786", "K821376", "K011957", "K955865", "K924930", "K102120", "K990177", "K252173", "K063650", "K897113", "K170037", "K860438", "K181170", "K060862", "K930017", "K102775", "K003770", "K821792", "K791186", "K943106", "K092263", "K823861", "K201874", "K053388", "K113051", "K952880", "K243394", "K863155", "K052863", "K140939", "K923992", "K120574", "K023289", "K770132", "K812980", "K092648", "K802270", "K861488", "K884520", "K032451", "K150638", "K063404", "K063806", "K241943", "K081845", "K072885", "K842363", "K943531", "K811102", "K970165", "K802168", "K141943", "K101401", "K911450", "K970158", "K070594", "K093905", "K072588", "K181216", "K844179", "K922975", "K822113", "K874415", "K833982", "K811141", "K062019", "K820220", "K884521", "K901953", "K083688", "K792564", "K926292", "K791713", "K800125", "K173973", "K050597", "K880923", "K121379", "K790733", "K982174", "K140575", "K061094", "K231778", "K841529", "K822635", "K863546", "K820393", "K041524", "K970839", "K902859", "K162877", "K092148", "K093886", "K911804", "K983219", "K111116", "K252663", "K894426", "K921821", "K812958", "K772065", "K841757", "K802583", "K071526", "K181695", "K950484", "K923809", "K010925", "K001686", "K910847", "K844912", "K002951", "K781159", "K040642", "K872482", "K192604", "K220107", "K982910", "K112006", "K820746", "K921726", "K993167", "K110083", "K222207", "K131252", "K123637", "K081521", "K812642", "K081670", "K103318", "K083122", "K093633", "K972833", "K841279", "K112729", "K912533", "K093416", "K103211", "K121886", "K923704", "K041412", "K041223", "K151901", "K900744", "K163127", "K233486", "K201306", "K083526", "K020746", "K203449", "K896381", "K864105", "K162738", "K961687", "K801697", "K172875", "K131774", "K173060", "K083693", "K103625", "K082600", "K923444", "K022679", "K822888", "K895541", "K871354", "K002881", "K023366", "K021573", "K080181", "K984379", "K992788", "K981668", "K900313", "K843737", "K122560", "K895513", "K010793", "K964543", "K873549", "K854070", "K223120", "K861707", "K993449", "K884389", "K894316", "K090888", "K222644", "K861432", "K092847", "K021112", "K832508", "K894322", "K040574", "K190533", "K843424", "K053270", "K823858", "K914485", "K911336", "K782074", "K960861", "K032922", "K073179", "K100753", "K842688", "K030515", "K984056", "K993071", "K873151", "K890921", "K900314", "K941308", "K982580", "K073069", "K120146", "K802087", "K984577", "K903010", "K983981", "K143035", "K071212", "K111610", "K113743", "K180098", "K972203", "K922102", "K012691", "K032226", "K181166", "K251133", "K870861", "K800650", "K781161", "K812016", "K800114", "K902405", "K872466", "K051550", "K072926", "K121891", "K844081", "K060705", "K192307", "K970460", "K122438", "K121225", "K941309", "K022674", "K873215", "K101643", "K790809", "K780188", "K896735", "K900465", "K051895", "K022132", "K183364", "K810893", "K840345", "K901448", "K822835", "K902506", "K863228", "K790732", "K760663", "K881335", "K896736", "K864431", "K980208", "K860675", "K900315", "K831877", "K880054", "K852771", "K040540", "K800999", "K992133", "K092264", "K902084", "K081842", "K842122", "K884832", "K042468", "K896442", "K895486", "K090468", "K162832", "K791188", "K120931", "K896380", "K061090", "K201082", "K001646", "K984535", "K883865", "K862025", "K062093", "K110795", "K130171", "K883159", "K180779", "K850374", "K120670", "K900637", "K920113", "K111473", "K862604", "K253647", "K193228", "K881482", "K840119", "K050860", "K051767", "K072590", "K082724", "K914424", "K120639", "K871792", "K210384", "K905234", "K802118", "K872113", "K161450", "K790605", "K101803", "K142679", "K862810", "K914607", "K922314", "K060549", "K062793", "K001208" ], "registration_number": [ "", "3004050971", "1220908", "3003135857", "1225492", "3006446479", "3011213495", "3003908598", "3031369651", "3001104093", "3032026475", "9680215", "2518436", "3038562397", "2025816", "3010088563", "3038259592", "9610849", "8020893", "3014631252", "3020283264", "1218058", "2021710", "3009077524", "3010817335", "3007603826", "3006135941", "3010017366", "3016450067", "3007344957", "2085602", "2024500", "3016723884", "2221819", "3010952312", "2011171", "3013154126", "2112667", "2112020", "3018094310", "3029922922", "9611295", "1222088", "3007573469", "8030941", "3005783425", "3009156722", "3012667060", "3016618143", "3006240053", "3033571078", "3029906224", "2518422", "1625392", "3011190789", "3008102042", "1314417", "2134715", "3000143502", "3009129579", "3008867836", "8021084", "9611500", "3004748541", "3010291427", "3029845", "3006087789", "3025936435", "3030733800", "3033526676", "8010042", "3014766741", "3008264065", "1000122786", "3007238566", "3009107628", "3013095415", "3000126629", "3003697063", "9710602", "8030673", "3018783526", "3007549157", "1316463", "1218704", "9681384", "1722070", "3009609218", "3029871637", "1066270", "9680661", "3008496839", "9617566", "1922553", "3010317211", "3001400310", "3006783791", "3008363989", "1000604079", "3004428458", "3010157426", "3011205710", "3011120183", "3044156918", "3009302812", "3021607937", "3006807694", "9610531", "1219324", "3021947238", "3003862188", "3026740087", "3023272766", "3003477135", "3017520736", "8010939", "9615827", "3004604967", "3010882708", "3030446844", "3021244152", "3001421318", "3029227324", "3002797442", "1924066", "9611451", "2020676", "3010834934", "3030149975", "3009490946" ], "fei_number": [ "", "3004050971", "1220908", "3003135857", "3006446479", "3011213495", "3003908598", "3031369651", "3001104093", "3032026475", "3003080079", "2518436", "3038562397", "2025816", "3002807391", "3010088563", "3002807992", "3005979524", "3038259592", "3002807850", "3014631252", "3003513129", "3020283264", "1218058", "2021710", "3009077524", "3010817335", "3000957797", "3007603826", "3006135941", "3010017366", "3016450067", "3007344957", "1000058335", "2024500", "3016723884", "2221819", "3010952312", "2011171", "3013154126", "2112667", "2112020", "3018094310", "3002807626", "3029922922", "1222088", "3005783425", "3009156722", "3012667060", "3001237338", "3016618143", "3006240053", "3033571078", "3029906224", "2518422", "3002807907", "3011190789", "3002808696", "1314417", "3003244771", "3002808128", "3000143502", "3009129579", "3008867836", "3004748541", "3010291427", "3002808440", "3006087789", "3025936435", "3030733800", "3033526676", "1000115734", "3023530182", "3014766741", "3008264065", "2995", "1000122786", "3007238566", "3009107628", "1000117260", "3013095415", "3000126629", "3003697063", "3001084824", "3018783526", "3007549157", "1316463", "1000524541", "3009609218", "3029871637", "3008496839", "1922553", "3010317211", "3001400310", "3006783791", "3008363989", "1000604079", "3004428458", "3002806988", "3010157426", "3011205710", "3011120183", "3044156918", "3009302812", "3021607937", "3003952420", "3006807694", "3002924544", "3003007937", "1219324", "3021947238", "3003862188", "3026740087", "3023272766", "3003477135", "3017520736", "3004604967", "3010882708", "3004213967", "3021244152", "3000210616", "3030446844", "3001421318", "3029227324", "3002797442", "1924066", "2020676", "3010834934", "3030149975", "3009490946" ], "device_name": "Ventilator, Continuous, Facility Use", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5895", "device_class": "2" } } ] }