{ "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": "211253", "product_res_number": "Z-0738-2025", "event_date_initiated": "2024-11-22", "event_date_posted": "2024-12-20", "recall_status": "Open, Classified", "res_event_number": "95809", "product_code": "CHL", "k_numbers": [ "K200107" ], "product_description": "epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9.\n\nIntended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care.", "code_info": "Siemens Material Number: 11413517; UDI-DI: 00630414605838;\nSoftware Version Number: 4.14.9.", "firm_fei_number": "1219913", "recalling_firm": "Siemens Healthcare Diagnostics, Inc.", "address_1": "333 Coney St", "city": "East Walpole", "state": "MA", "postal_code": "02032-1516", "additional_info_contact": "Customer Service\n877-229-3711", "reason_for_recall": "Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.", "root_cause_description": "Software design", "action": "Siemens issued Urgent Medical Device Correction (UMDC) letter to U.S. customers by FedEx beginning on November 22, 2024. Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional\nreporting to their local competent authorities beginning on November 22, 2024.\nLetter states reason for recall, health risk and action to take:\n Please review this letter with your Medical Director to determine the appropriate course of\naction, including for any previously generated results, if applicable.\n If you are a distributor, please ensure your customers receive this UMDC letter.\n To avoid the issue, please follow one of the options below:\no Option 1: After completing a patient test, either log out or return to the home\npage before proceeding to the next patient test by pressing Close and Transmit \nbutton.\no Option 2: Before starting a new test, follow the steps outlined in Section 6.19\n Patient ID Lookup of the epoc System Manual with NXS Host and confirm the\ncorrect patient demographics. It is important to verify the demographics, as some\nof this data may be used for calculated analytes. If the demographics are\nincorrect, delete and re-enter the Patient ID and perform the PPID Lookup again.\n Complete and return the Field Correction Effectiveness Check Form attached to this letter\nwithin 30 days.\n Adverse reactions or quality problems experienced with the use of the affected products listed\nin the above table may be reported to the FDA s MedWatch Adverse Event Reporting program\neither online, by regular mail or by fax.\n Please retain this letter with your epoc System Manual with NXS Host or place the letter near\nthe affected instrument for reference. Please also forward this letter to those who may have\nreceived this product.\nFor any questions, you may call Siemens Healthineers Technical Solutions Center at\n877-229-3711, available daily from 7:00 AM to 11:00 PM EST.\n\nThe issue will be resolved in the", "product_quantity": "1 unit", "distribution_pattern": "Nationwide\nForeign:\nAlbania\nAngola\nArgentina\nAustralia\nAustria\nBahrain\nBangladesh\nBelarus\nBelgium\nBolivia\nBosnia and Herzegovina\nBrazil\nCambodia\nCanada\nChile\nChina\nColombia\nCroatia\nCzech Republic\nDenmark\nEcuador\nEgypt\nEstonia\nFinland\nFrance\nGermany\nGhana\nGreece\nGuadeloupe\nHong Kong\nHungary\nIceland\nIndia\nIndonesia\nIraq\nIreland\nIsrael\nItaly\nJapan\nJordan\nKazakhstan\nKuwait\nLatvia\nLithuania\nLuxembourg\nMacau\nMadagascar\nMalaysia\nMexico\nMonaco\nMongolia\nMorocco\nMyanmar\nNetherlands\nNew Caledonia\nNew Zealand\nNorway\nParaguay\nPeru\nPhilippines\nPoland\nPortugal\nRepublic Korea\nRomania\nRussian Federation\nSaudi Arabia\nSingapore\nSlovakia\nSlovenia\nSouth Africa\nSpain\nSri Lanka\nSwaziland\nSweden\nSwitzerland\nThailand\nTunisia\nTurkey\nUkraine\nUnited Arab Emirates\nUnited Kingdom Great Britain\nUruguay\nVietnam", "openfda": { "k_number": [ "K820597", "K895181", "K860057", "K945240", "K954711", "K063376", "K832779", "K041874", "K012478", "K013729", "K043218", "K865036", "K991417", "K993789", "K954612", "K992859", "K891578", "K000103", "K131988", "K193246", "K935655", "K200492", "K953935", "K936081", "K093280", "K904513", "K771253", "K890827", "K914560", "K223857", "K973367", "K023567", "K031560", "K123748", "K982928", "K141907", "K240998", "K122539", "K760229", "K131703", "K221900", "K122642", "K812552", "K142898", "K131126", "K961657", "K935121", "K771822", "K840300", "K844781", "K160153", "K211559", "K252207", "K020297", "K800224", "K944089", "K014295", "K854608", "K130144", "K963964", "K831012", "K864445", "K160412", "K943643", "K853840", "K963800", "K831010", "K955793", "K810724", "K792230", "K841609", "K002290", "K831020", "K902267", "K022746", "K820744", "K760748", "K151978", "K833536", "K100777", "K200107", "K980991", "K940918", "K012058", "K111188", "K770736", "K961161", "K935830", "K980130", "K831019", "K884267", "K863880", "K922922", "K780716", "K831016", "K871397", "K120197", "K852676", "K813517", "K924758", "K831379", "K954482", "K002613", "K821483", "K882941", "K934907", "K990092", "K831021", "K173797", "K840468", "K936203", "K913927", "K002738", "K772307", "K882209", "K812090", "K831015", "K151982", "K133407", "K021515", "K771147", "K850360", "K980523", "K974396", "K223608", "K823570", "K914166", "K812623", "K924497", "K110648", "K853405", "K842519", "K904188", "K833534", "K935069", "K974526", "K840843", "K051804", "K832981", "K831024", "K173403", "K831025", "K984384", "K760969", "K831013", "K200986", "K800757", "K884143", "K192240", "K994346", "K823750", "K943570", "K932642", "K244014", "K961335", "K852790", "K881188", "K831018", "K873577", "K050423", "K946206", "K970710", "K922631", "K942616", "K061974", "K915087", "K895317", "K831023", "K110416", "K943882", "K021713", "K834601", "K810308", "K203790", "K122729", "K800271", "K142220", "K982277", "K080370", "K992834", "K151856", "K111897", "K781968", "K962021", "K903965", "K844295", "K831017", "K230285" ], "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": [ "2432235", "1219029", "1220972", "9610633", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "9610126", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "1217183", "8030478", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ], "fei_number": [ "2432235", "1219029", "3002806559", "1220972", "3002807968", "2050012", "3015997711", "3006198300", "3012104670", "3005643513", "1219913", "2431530", "3037000637", "3002637618", "3014506106", "1222035", "1036362", "3001576181", "3007490412", "3007662974", "1000455123", "1181121", "2245578", "3013513377", "3023162659", "3002806693", "1217183", "3004102403", "3012817228", "1717966", "1220649", "3003971136", "3004959793", "3003795116" ] } } ] }