{ "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": "198394", "product_res_number": "Z-1214-2023", "event_date_initiated": "2022-12-12", "event_date_posted": "2023-03-03", "recall_status": "Open, Classified", "res_event_number": "91639", "product_code": "CHL", "k_numbers": [ "K061597" ], "product_description": "epoc Host 2 as follows:\nProduct SMN \nepoc Host \t\t10736387\nepoc Host 2, Canada\t10736388\nepoc Host 2, China\t\t10736389\nepoc Host 2, Japan\t\t10736390\nepoc Host 2, Refurbished 10736393\nepoc Host 2, Canada, Refurbished\t 10736394\nepoc Host 2, Japanese, Refurbished\t\t\t 10736395\nepoc Host 2, Chinese, Refurbished\t\t\t 10736433\nepoc Host 2, US (MC55X)\t\t\t\t\t\t 11413524\nepoc Host 2, ROW (MC55X)\t\t\t\t\t\t 11413528\nepoc Host 2, India (MC55X)\t\t\t\t\t\t 11413541\nepoc Host 2, China (MC55X)\t\t\t\t\t 11413542\nepoc Host 2, Japan (MC55X)\t\t\t\t\t 11413543\nepoc Host 2 (MC55X) - US - Refurbished\t\t 11413601\n\"epoc Host 2 (MC55X) - ROW -Refurbished\"\t 11413602\nepoc Host 2 (MC55X) - India - Refurbished\t 11413603\nepoc Host 2 (MC55X) - Japan - Refurbished\t 11413604", "code_info": "Host Software Version /Sensor Configuration: 3.37.3/41.1\n\nProduct Description\t\t\tSiemens Material Number (SMN)\tUnique Device Identification (UDI-DI)\t\t\nepoc Host 2\t\t\t\t\t\t\t10736387\t 00809708052898;\t\t\nepoc Host 2, Canada\t\t\t\t10736388\t 00809708069117;\t\nepoc Host 2, China\t\t\t\t\t10736389 00809708097219;\t\t\nepoc Host 2, Japan\t\t\t\t\t10736390\t 00809708075576;\t\t\nepoc Host 2, Refurbished\t\t\t10736393\t 00809708053901;\t\t\nepoc Host 2, Canada, Refurbished\t10736394\t 00809708069124;\t\t\nepoc Host 2, Japanese, Refurbished 10736395\t 00809708075583;\t\t\nepoc Host 2, Chinese, Refurbished 10736433\t 00809708097226;\t\t\nepoc Host 2, US (MC55X)\t\t\t11413524\t 00630414606460;\t\t\nepoc Host 2, ROW (MC55X)\t\t\t11413528\t 00630414606378;\t\t\nepoc Host 2, India (MC55X)\t\t\t11413541\t 00630414608617;\t\t\nepoc Host 2, China (MC55X)\t\t11413542\t 00630414608624;\t\t\nepoc Host 2, Japan (MC55X)\t\t11413543\t 00630414608532;\t\t\nepoc Host 2 (MC55X) - US - Refurbished\t11413601\t 00630414615004;\t\t\n\"epoc Host 2 (MC55X) - ROW -\nRefurbished\"\t\t\t\t\t\t\t11413602 \t00630414614885;\t\t\nepoc Host 2 (MC55X) - India - Refurbished \t1413603\t 00630414614762;\t\t\nepoc Host 2 (MC55X) - Japan - Refurbished\t11413604\t 00630414614892.", "firm_fei_number": "3002637618", "recalling_firm": "Siemens Healthcare Diagnostics Inc", "address_1": "2 Edgewater Dr", "city": "Norwood", "state": "MA", "postal_code": "02062-4637", "additional_info_contact": "SAME\n781-269-3000", "reason_for_recall": "pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure", "root_cause_description": "Under Investigation by firm", "action": "Siemens has issued an Urgent Medical Device Correction POC 23-004.A.US on December 12, 2022 and Urgent Field Safety Notice POC 23-004.A.OUS to customers informing them of the issue and providing workaround for customers to use until the affected sensor configuration/software version expires on June 12, 2023. The next sensor configuration with the fix and its corresponding sw version will be available to customers in April 2023.\n\nLetter states reason for recall, health risk and action to take:\n\" Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.\n\" If you are a distributor, please ensure your customers receive this UMDC letter.\n\" If you perform QC tests at barometric pressures equal to or above 730 mmHg (97 kPa), no additional action is required.\n\" If you perform QC tests at barometric pressures less than 730 mmHg (97 kPa), apply barometric correction factors before comparing the gas readings with the published value assignments. \n\n***Important Note*** The above barometric correction factor should be applied only to epoc System Software sensor configuration 41.1, epoc Host 2 SW Version 3.37.3 and epoc NXS Host SW Version 4.10.6, which expires June 12, 2023. Following the expiration of this sensor configuration and the software version refer to the epoc System Manual Section 9.5.1 for the appropriate Barometric Correction factor to apply.\" Please review this letter with your Medical Director.\" Please retain this letter with your laboratory records and forward this letter to those who may have received the affected product.\n\nQuestions, please contact your Siemens Healthineers Technical Solution Center or your local Siemens Healthineers technical support representative.", "product_quantity": "22,156 units", "distribution_pattern": "Nationwide\nForeign:\nAlgeria\nArgentina\nAustralia\nAustria\nBahrain\nBelarus\nBelgium\nBolivia\nBrazil\nCambodia\nCanada\nChile\nChina\nColombia\nCroatia\nCzech Republic\nDenmark\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nFren.Polynesia\nGeorgia\nGermany\nGreece\nGuadeloupe\nHong Kong\nHungary\nIceland\nIndia\nIndonesia\nIran\nIreland\nIsrael\nItaly\nJapan\nJordan\nKazakhstan\nKenya\nKuwait\nLaos\nLatvia\nLithuania\nLuxembourg\nMalaysia\nMali\nMartinique\nMexico\nMyanmar\nNetherlands\nNew Caledonia\nNew Zealand\nNorway\nPapua Nw Guinea\nPeru\nPhilippines\nPoland\nPortugal\nQatar\nRepublic Korea\nReunion\nRomania\nRussian Fed.\nSan Marino\nSingapore\nSlovakia\nSlovenia\nSolomon Islands\nSouth Africa\nSpain\nSweden\nSwitzerland\nTaiwan\nThailand\nTunisia\nTurkey\nU.A.E.\nUkraine\nUnited Kingdom\nUruguay\nVietnam", "openfda": { "k_number": [ "K890827", "K142220", "K012478", "K932642", "K844295", "K884267", "K133407", "K151982", "K961161", "K935121", "K131988", "K012058", "K936081", "K100777", "K050423", "K831010", "K111897", "K192240", "K945240", "K924758", "K935655", "K230285", "K760748", "K772307", "K943570", "K863880", "K131126", "K200986", "K110648", "K853405", "K831019", "K813517", "K991417", "K973367", "K122539", "K244014", "K970710", "K834601", "K013729", "K043218", "K120197", "K984384", "K821483", "K852676", "K935069", "K780716", "K781968", "K771147", "K002613", "K812552", "K954612", "K831023", "K980991", "K031560", "K820597", "K904188", "K831025", "K063376", "K014295", "K223608", "K974526", "K853840", "K902267", "K936203", "K860057", "K800271", "K840843", "K992859", "K142898", "K854608", "K221900", "K962021", "K160412", "K760229", "K770736", "K831016", "K963964", "K955793", "K982928", "K842519", "K110416", "K881188", "K173797", "K831012", "K810308", "K041874", "K980523", "K831018", "K023567", "K080370", "K831024", "K922922", "K151856", "K111188", "K961335", "K934907", "K915087", "K940918", "K130144", "K982277", "K051804", "K935830", "K961657", "K954482", "K131703", "K865036", "K240998", "K922631", "K953935", "K211559", "K792230", "K160153", "K800757", "K812090", "K882209", "K061974", "K832981", "K122642", "K963800", "K141907", "K022746", "K990092", "K943882", "K946206", "K913927", "K844781", "K924497", "K895317", "K831017", "K833536", "K942616", "K833534", "K820744", "K823750", "K823570", "K002290", "K193246", "K223857", "K852790", "K832779", "K994346", "K122729", "K021515", "K831013", "K895181", "K864445", "K831379", "K993789", "K200107", "K000103", "K840468", "K903965", "K873577", "K850360", "K203790", "K884143", "K093280", "K871397", "K944089", "K891578", "K151978", "K974396", "K882941", "K002738", "K123748", "K831015", "K760969", "K831021", "K904513", "K914166", "K812623", "K980130", "K200492", "K914560", "K841609", "K992834", "K800224", "K954711", "K831020", "K020297", "K252207", "K771822", "K021713", "K943643", "K173403", "K840300", "K810724", "K771253" ], "device_name": "Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph", "medical_specialty_description": "Clinical Chemistry", "regulation_number": "862.1120", "device_class": "2", "registration_number": [ "3014506106", "3013513377", "3012817228", "1000455123", "3002637618", "2050012", "9610633", "1217183", "3007490412", "3023162659", "2431530", "3002807968", "3004102403", "8030478", "3012104670", "3037000637", "1717966", "3015997711", "1219913", "3003795116", "3003971136", "1222035", "9610126", "2245578", "1181121", "1036362", "3007662974", "3006198300", "1220972", "1219029", "1220649", "2432235", "3005643513", "3004959793" ], "fei_number": [ "3014506106", "3013513377", "3012817228", "1000455123", "3002637618", "2050012", "1217183", "3007490412", "3023162659", "2431530", "3002807968", "3004102403", "3012104670", "3037000637", "1717966", "3015997711", "1219913", "3003795116", "3003971136", "1222035", "2245578", "1181121", "1036362", "3002806559", "3007662974", "3006198300", "3001576181", "1220972", "1219029", "1220649", "2432235", "3002806693", "3005643513", "3004959793" ] } } ] }