{ "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": "121598", "product_res_number": "Z-0106-2014", "event_date_initiated": "2012-09-17", "event_date_posted": "2013-10-29", "recall_status": "Terminated", "event_date_terminated": "2015-04-01", "res_event_number": "66166", "product_code": "CHL", "k_numbers": [ "K031560" ], "product_description": "Siemens RAPIDLab 1245 system blood gas analyzer\n\n\nProduct Usage:\nRAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb", "code_info": "All Serial Numbers", "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": "781-269-3000", "reason_for_recall": "RAPIDPoint 400 Series, RAPIDPoint 500, or\nRAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "Siemens Healthcare sent an Urgent Field Safety Notification letter dated September 2013 via Federal Express, to affected Siemens domestic customers. Effected Siemens customers outside the US was provided a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each countries local regulations and procedures. Previously Siemens Healthcare had issued a Customer Notification on August 23, 2012. The letter identified the affected product, issue, information to mitigate the issue and actions to be taken. The firm will issue an upgrades software to users. For questions contact your local Customer Care Center - Technical Support Representative at 1-877-229-3711.", "product_quantity": "274 units", "distribution_pattern": "Worldwide Distribution - USA Nationwide and in the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia Herzeg., Botswana, Brazil, Brunei, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Fren.Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Mayotte, Netherlands, New Caledonia, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, U.A.E., United Kingdom, Vatikancity, Venezuela, Vietnam,", "openfda": { "k_number": [ "K946206", "K840468", "K050423", "K914560", "K122729", "K844781", "K831021", "K831016", "K970710", "K932642", "K771253", "K760969", "K823750", "K980130", "K810724", "K934907", "K973367", "K980991", "K771822", "K935830", "K813517", "K240998", "K953935", "K820744", "K852790", "K142220", "K173403", "K021515", "K924497", "K954612", "K151978", "K160412", "K922922", "K831025", "K080370", "K991417", "K093280", "K021713", "K840843", "K012478", "K831010", "K940918", "K943882", "K031560", "K882941", "K842519", "K014295", "K903965", "K820597", "K760229", "K022746", "K110648", "K831379", "K100777", "K130144", "K122539", "K000103", "K844295", "K860057", "K133407", "K223857", "K962021", "K831017", "K160153", "K173797", "K850360", "K954482", "K151982", "K041874", "K002738", "K812090", "K882209", "K840300", "K823570", "K904188", "K831015", "K863880", "K002613", "K984384", "K051804", "K193246", "K935655", "K990092", "K963964", "K881188", "K111897", "K922631", "K993789", "K954711", "K800224", "K992859", "K871397", "K890827", "K012058", "K915087", "K200986", "K913927", "K760748", "K131126", "K831024", "K792230", "K891578", "K854608", "K936203", "K043218", "K873577", "K834601", "K884143", "K955793", "K200107", "K945240", "K192240", "K131988", "K980523", "K982928", "K122642", "K800271", "K961657", "K244014", "K812552", "K942616", "K821483", "K924758", "K833534", "K023567", "K943570", "K812623", "K961335", "K831019", "K944089", "K895317", "K002290", "K110416", "K832779", "K142898", "K865036", "K831023", "K200492", "K895181", "K963800", "K211559", "K853405", "K935069", "K832981", "K131703", "K772307", "K982277", "K013729", "K831020", "K852676", "K831013", "K120197", "K992834", "K935121", "K833536", "K904513", "K864445", "K841609", "K252207", "K853840", "K810308", "K936081", "K771147", "K203790", "K151856", "K914166", "K020297", "K230285", "K141907", "K063376", "K781968", "K111188", "K902267", "K943643", "K780716", "K061974", "K884267", "K974526", "K800757", "K123748", "K974396", "K221900", "K770736", "K223608", "K961161", "K831012", "K994346", "K831018" ], "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": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "9610633", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "9610126", "1220649", "1181121", "1222035", "3037000637", "1219913", "8030478", "3007662974", "3007490412", "3002807968", "3012817228", "3006198300" ], "fei_number": [ "3002637618", "1220972", "3005643513", "3013513377", "3003795116", "1036362", "2431530", "3004102403", "1217183", "3012104670", "2245578", "3004959793", "1000455123", "3014506106", "2432235", "1717966", "2050012", "3023162659", "3015997711", "1219029", "3003971136", "1220649", "1181121", "1222035", "3037000637", "1219913", "3007662974", "3007490412", "3002806693", "3002807968", "3012817228", "3006198300", "3001576181", "3002806559" ] } } ] }