{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "95499", "product_res_number": "Z-0488-2011", "event_date_initiated": "2010-09-22", "event_date_posted": "2010-11-29", "recall_status": "Terminated", "event_date_terminated": "2013-09-05", "res_event_number": "56816", "product_code": "MKJ", "k_numbers": [ "K003565", "K013425" ], "product_description": "HeartStart FR2+ AED with Text Display, Model 989803148611. This product is G2005 Update in accordance with the American Heart Association 2005 Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (ECC).\n\nThe label of the device states: \"HEARTSTART...FR2+ Automated External Defibrillator...Manufactured by: Philips Medical Systems Seattle, WA 98121\".", "code_info": "Serial Numbers:   0205001035, 0307230040, 0307230281, 1204000353, 1204000405, and 1204000766.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems", "address_1": "2301 5th Ave Ste 200 2301 5th Ave", "address_2": "Ste 200", "city": "Seattle", "state": "WA", "postal_code": "98121", "additional_info_contact": "800-263-3342", "reason_for_recall": "A flash memory component in the HeartStart FR2+ and Automated External Defibrillator was improperly relabeled by a third party. Therefore the component could not be identified by its source, quality, and date of manufacture.", "root_cause_description": "Nonconforming Material/Component", "action": "On 10/5/10, Philips began sending out the Voluntary Medical Device Removal notification letter to their consignees.\n\nThis letter informs the consignees that Philips Healthcare is conducting a voluntary product removal of a limited number of HeartStartFR2+ automated external defibrillators (AEDs), model numbers M3860A, M3861A, M3849A, and M3841A, manufactured by Philips and shipped between March 2007 and August 2010. \n\nThe owners of affected AEDs are advised to run a battery insertion test. If it passes, the AED should remain in service until its replacement is received. Philips will be replacing affected units.\n\nThe consignees can visit the firm's website www.philips.com/FR2AEDAction or contact Philips at 1-800-263-3342 for any information or support concerning the issue.", "product_quantity": "6 units", "distribution_pattern": "Devices were distributed to hospitals, medical facilities, and distributors through out the US and to foreign consignees. \n\nForeign consignees including countries:\n\nAlgeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Ecuador, El Salvador, Finland, France, French Guiana, Georgia, Germany, Ghana, Gibraltar, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Japan, Jordan, Kampuchea, Kenya, Korea, Latvia, Lebanon, Libya, Luxembourg, Malaysia, Malta & Gozo, Mexico, Netherland, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Peru, Philippines, Portugal, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates, United Kingdom, Vietnam, and Zimbabwe.", "openfda": { "k_number": [ "K982710", "K042404", "K051632", "K883584", "K962359", "K040438", "K981802", "K123881", "K012766", "K032439", "K955882", "K033896", "K052161", "K033642", "K120406", "K860676", "K993533", "K122839", "K955923", "K954957", "K133441", "K990762", "K063510", "K052465", "K040479", "K892005", "K992977", "K982992", "K041459", "K131494", "K013425", "K110526", "K142803", "K984582", "K110154", "K030898", "K072233", "K040256", "K882067", "K023854", "K981737", "K100565", "K061707", "K972418", "K990106", "K062233", "K133484", "K081828", "K013896", "K983393", "K150198", "K892065", "K932931", "K020288", "K130153", "K052057", "K014157", "K110361", "K112761", "K022210", "K060559", "K014209", "K870622", "K935922", "K103567", "K965117", "K934692", "K041892", "K003819", "K942344", "K955854", "K040637", "K080421", "K133239", "K143714", "K992543", "K131525", "K003565", "K012428", "K051076", "K133659", "K041883", "K111594", "K051475", "K052316", "K092598", "K133269", "K003228", "K020743", "K971149", "K993072", "K002445", "K991007", "K130454", "K020715", "K082090", "K110978", "K953204", "K142915", "K926172", "K010918", "K142709", "K042088", "K955628", "K970719", "K121853", "K896919", "K033771", "K080903", "K970741", "K941262", "K031187", "K050004", "K012030", "K002280", "K112432", "K120536", "K040775", "K973486", "K972241", "K091943", "K113787", "K041067", "K020203", "K954504", "K984286", "K141231", "K952101", "K991871", "K980857", "K110825", "K120350", "K092391", "K102972", "K081371", "K000638", "K011901", "K063119", "K954609", "K072430", "K042417", "K993745", "K925936", "K081259", "K970391", "K103186", "K072812", "K062177", "K073716", "K991910", "K080232", "K063375", "K022929", "K942850", "K082937", "K022732", "K110742", "K003548", "K122600", "K010207", "K032421", "K091548", "K021168", "K011541", "K020984", "K982264", "K073089", "K943698", "K131550", "K940445", "K130684", "K122758", "K991556", "K141774", "K993036", "K110168", "K012197", "K090989", "K040056", "K081081", "K002079", "K941970", "K011388", "K091265", "K032051", "K955890", "K031987", "K072923", "K883341", "K150055", "K983307", "K033474", "K883344", "K972970", "K982025", "K033144", "K072596", "K010214", "K960329", "K001725", "K033275", "K062970", "K002806", "K011144", "K070455", "K964991", "K060934", "K141795", "K102496", "K091561", "K932028", "K120907", "K111693", "K051134", "K971148", "K983287", "K071025", "K082861", "K002232", "K142430", "K955828", "K042007", "K010634", "K853564", "K040404", "K010257", "K021453", "K062537" ], "pma_number": [ "P200005", "P160034", "P170018", "P160033", "P160028", "P160015", "P160022", "P180028", "P190013", "P160032", "P210015", "P160008", "P160026", "P200004", "P200007", "P160012", "P190007" ], "registration_number": [ "", "1720929", "3004906872", "3010839093", "3038259592", "3008717264", "3020460367", "3013500228", "3030446844", "3004123209", "3003521780", "1930027", "3014572985", "1320894", "3010030355", "3010317211", "3000126629", "1218058", "3002714378", "1423537", "8020045", "3009886119", "1317188", "3030733800", "3043226252", "3030677", "3013557562", "3010783192", "1223925", "3015876", "1921846", "3013826848", "3003537036", "1220908", "3027815", "3009077524", "3003867964", "3029871637", "3012972516", "9681860", "3005621729", "3002807314", "3026976873", "3003800159", "3015997711", "3012104670", "3017422354", "3011823740", "3014579161", "3005906887", "3007029079", "3026007685", "3004035727", "3015134086", "3013517171", "3021559257", "3012502601", "2132111", "3012607778", "1219103", "3012494290", "3013596024", "9681191", "3010703925", "1423662", "2112020", "3006108746" ], "fei_number": [ "", "1720929", "3004906872", "3010839093", "3038259592", "3008717264", "3020460367", "3013500228", "3030446844", "3004123209", "3003521780", "1930027", "3014572985", "3010030355", "3010317211", "3000126629", "1218058", "3002714378", "3009886119", "1317188", "3030733800", "3043226252", "3013557562", "3000215273", "3010783192", "1000148701", "3015876", "1921846", "3013826848", "3003537036", "1220908", "1000305720", "3009077524", "3003867964", "3003491392", "3029871637", "3012972516", "3001236905", "3005621729", "3002807314", "3026976873", "3001451571", "3003800159", "1000140026", "3015997711", "3012104670", "3017422354", "3011823740", "3014579161", "3005906887", "3007029079", "3026007685", "3004035727", "3015134086", "3013517171", "3021559257", "3012502601", "1000127185", "3012607778", "3012494290", "3013596024", "1000524572", "3010703925", "2112020", "3006108746", "6736", "3008207730" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }