{ "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": 1 } }, "results": [ { "cfres_id": "198442", "product_res_number": "Z-1217-2023", "event_date_initiated": "2023-02-01", "event_date_posted": "2023-03-03", "recall_status": "Open, Classified", "res_event_number": "91659", "product_code": "MKJ", "pma_numbers": [ "P160008" ], "product_description": "Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,\nSAM 360P fully automatic defibrillator,\nSAM 500P semi-automatic defibrillator with CPR Advisor", "code_info": "REF/UDI-DI/Serial Numbers:\nSAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062;\nSAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881;\nSAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080", "firm_fei_number": "3004123209", "recalling_firm": "HeartSine Technologies Ltd", "address_1": "207 Airport Road West", "city": "Belfast", "country": "United Kingdom", "additional_info_contact": "+44 2890939400", "reason_for_recall": "Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.", "root_cause_description": "Process control", "action": "On 2/1/23, correction notices were mailed to customers who were asked to do the following: \n\n1) Confirm that the device has incorrect language voice prompts by using the Device Language Check.\n2) If the device is found to have incorrect language configuration, remove it form use. The recalling firm will provide a replacement device.\n3) Inform the recalling firm of any of the subject devices have been distributed to other organizations.\n4) Complete and return the acknowledgement form to heartsinesupport@stryker.com\n\nIf you have questions or concerns contact Customer Support at +44 28 9093 9400, 9:00 A.M. to 5:00 P.M. (GMT), Monday Friday or by email at heartsinesupport@stryker.com.\n\nLanguage Check:\n1) Place device face up on a flat surface and slide the PAD-Pak into the device until you hear a \"double click\".\n2) Verify the green status indicator is blinking.\n3) Press the On/Off button. Liston for, but do not follow the voice prompts to ensure no warning messages are played and that the device prompts are in the expected language.\n4) Press On/Off button to turn off the device.", "product_quantity": "13", "distribution_pattern": "US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR\n\nOUS: Australia, Czechia, Canada, New Zealand", "openfda": { "k_number": [ "K021453", "K980857", "K130454", "K011541", "K142803", "K112761", "K040056", "K113787", "K982264", "K012766", "K982710", "K082937", "K010214", "K130153", "K983393", "K870622", "K042404", "K051134", "K073089", "K011144", "K860676", "K022210", "K052057", "K023854", "K010918", "K082090", "K041067", "K063510", "K012197", "K941970", "K883341", "K040637", "K091265", "K993072", "K110526", "K112432", "K131494", "K002280", "K032051", "K000638", "K943698", "K960329", "K955828", "K072596", "K983307", "K052316", "K090989", "K993745", "K110825", "K111693", "K072812", "K121853", "K150198", "K892005", "K123881", "K954957", "K002445", 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"K102496", "K100565", "K052161", "K962359", "K133659", "K021168", "K003228", "K010207", "K942850", "K040775", "K133441", "K052465", "K092598", "K942344", "K993036", "K072923", "K022732", "K991910", "K991556", "K992543", "K981802", "K022929", "K031187", "K955854", "K071025", "K991007", "K972241", "K091943", "K072233", "K062177", "K141795", "K003548", "K081371", "K120406", "K965117", "K954504", "K060934", "K011901", "K020984", "K062537", "K011388", "K964991", "K033771", "K051076", "K103567", "K133239", "K955882", "K970741", "K002079", "K033144", "K955890", "K063119", "K103186", "K953204", "K952101", "K012428", "K142430", "K012030", "K954609", "K883584", "K031987", "K972970", "K926172", "K122600", "K110978", "K892065", "K080421", "K091561", "K072430", "K060559", "K110168", "K143714", "K982025", "K970719", "K081828", "K992977", "K882067", "K110154", "K092391", "K081259" ], "pma_number": [ "P160015", "P160028", "P210015", "P160033", "P160034", "P160026", "P160012", "P200004", "P170018", "P200007", "P180028", "P190013", "P200005", "P160022", "P160032", "P190007", "P160008" ], "registration_number": [ "", "3005906887", "2132111", "1720929", "3030733800", "3005621729", "3003867964", "3004035727", "1220908", "3015134086", "3009886119", "3021632375", "3003521780", "3014572985", "1218058", "8020045", "3006108746", "3011823740", "3012494290", "1219103", "3013500228", "3007029079", "3010839093", "9681860", "3013596024", "3002807314", "3012972516", "3030677", "3021559257", "9681191", "3008717264", "3010703925", "1930027", "3012104670", "3014579161", "3009077524", "3015997711", "1317188", "3010317211", "3020460367", "3043226252", "3000126629", "3038259592", "3027815", "3003800159", "3017422354", "3004906872", "1423537", "2112020", "3013557562", "3013517171", "3026976873", "3026007685", "1223925", "3029871637", "3013826848", "3012502601", "3030446844", "3003537036", "3010030355", "3015876", "1921846", "1423662", "3010783192", "1320894", "3002714378", "3004123209", "3012607778" ], "fei_number": [ "", "1000305720", "3005906887", "1720929", "3030733800", "3005621729", "3003867964", "3004035727", "1220908", "3015134086", "3009886119", "3021632375", "3003521780", "3014572985", "1218058", "6736", "3006108746", "3011823740", "3012494290", "3013500228", "3007029079", "3010839093", "3013596024", "3002807314", "3012972516", "3021559257", "3008717264", "3003491392", "3010703925", "1930027", "3012104670", "1000140026", "3014579161", "1000148701", "3009077524", "3008207730", "3001451571", "3015997711", "1317188", "3010317211", "3020460367", "3043226252", "3000126629", "3038259592", "3003800159", "3017422354", "3004906872", "2112020", "3013557562", "3013517171", "3026976873", "3026007685", "3029871637", "3013826848", "3012502601", "3030446844", "3003537036", "3010030355", "3001236905", "3015876", "1921846", "1000524572", "3010783192", "3002714378", "3004123209", "1000127185", "3000215273", "3012607778" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }