{ "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": "121596", "product_res_number": "Z-0104-2014", "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": [ "K113216" ], "product_description": "Siemens RAPIDPoint 500 system blood gas analyzer\r\n\r\nProduct Usage:\r\nRAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili", "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\r\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": "2152 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": [ "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" ] } } ] }