{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189144", "product_res_number": "Z-0081-2022", "event_date_initiated": "2021-02-09", "event_date_posted": "2021-10-08", "recall_status": "Open, Classified", "res_event_number": "88637", "product_code": "MKJ", "pma_numbers": [ "P160029" ], "product_description": "Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A", "code_info": "Affected serial numbers for Model # M5066A:\nA11K-03264,\nA07A-01278,\nB07F-01268,\nA10G-05443,\nA06E-00929,\nA06L-01867,\nA06L-01678,\nA07J-05837,\nA10C-03623,\nM5066A-ABD,\nA07K-02685,\nA09H-03908,\n 0205142344,\n\nExpansion - additional serial numbers for Model # M5066A:\nA11K-08837,\n\nAffected Serial numbers for Model # M5067A:\nA06K-02421.", "firm_fei_number": "1000524572", "recalling_firm": "Philips North America LLC", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Customer Services\n1800-722-9377", "reason_for_recall": "Customers were not notified of previous recalls associated with various defibrillator models.", "root_cause_description": "Process control", "action": "On February 11, 2021, Philips issued a \"Urgent - Safety Notification\" to affected consignees via certified Mail. In addition to notifying consignees that may have been omitted from notification of one or more recalls, Philips asked affected consignees to take \n\n1.\tTo acknowledge receipt of this notification, please complete and return the Customer Reply Form by email or by fax by February 15, 2021. \n\nEmail to: ECR.Recall.Response@Philips.com\nOr, Fax: 1 (833) 371-1011\n\n2.\tA Philips representative will reach out to you to help you identify any affected AED. \n\n3.\tAfter it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be provided.\n\n4.\tThe affected AED may remain in service until you receive a replacement Philips AED.\n\n5. Philips will exchange affected devices with a replacement Philips AED free of charge.\n\n6. If you need any further information or support concerning this issue, please contact Philips at 1 (800) 263-3342.\n\n7. Adverse reactions or quality problems experienced with the use of this product\nmay be reported to the FDA s Med Watch Adverse Event Reporting program\neither online, by regular mail or by fax.", "product_quantity": "15 units", "distribution_pattern": "U.S.: CA, CT, FL, GA, IN, MI, MO, NJ, NY, OH, TX, and WA.\n\nInternational distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland.", "openfda": { "k_number": [ "K970741", "K883344", "K142803", "K954504", "K955923", "K141231", "K072923", "K981737", "K032051", "K982710", "K860676", "K111693", "K003565", "K981802", "K972241", "K122839", "K110825", "K992543", "K142915", "K150198", "K014157", "K091265", "K062233", "K042007", "K091561", "K012197", "K081371", "K012766", "K110168", "K954609", "K990106", "K020203", "K002079", "K001725", "K002445", "K971148", "K072430", "K080232", "K031187", "K081828", "K051475", "K110742", "K010634", "K980857", "K052465", "K970391", "K142430", "K964991", "K983393", 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"K092391", "K993533", "K991556", "K991871", "K071025", "K020743", "K853564", "K072812", "K150055", "K100565", "K112761", "K003228", "K012428", "K023854", "K011541", "K892005", "K941262", "K040775", "K091548", "K954957", "K952101", "K130153", "K013425", "K955882", "K942344", "K130684", "K041067", "K032439", "K051134", "K972970", "K033896", "K934692", "K932028", "K955890", "K061707", "K012030", "K031987", "K941970", "K971149", "K051076", "K121853", "K010214", "K993036", "K040256", "K032421", "K935922", "K091943", "K072233", "K082861", "K063119", "K120907", "K082090", "K113787", "K131550", "K010207", "K955854", "K060934", "K011144", "K041892", "K062177", "K982264", "K090989", "K081081", "K021453", "K022210", "K111594", "K042404", "K120536", "K925936", "K010918", "K033275", "K133484", "K142709", "K102496", "K983307", "K133239", "K092598", "K122758", "K081259", "K042088", "K133441", "K896919", "K011388", "K003819", "K033642", "K022929", "K080421", "K110154" ], "pma_number": [ "P160032", "P190013", "P160034", "P160008", "P190007", "P180028", "P200007", "P160012", "P170018", "P210015", "P200005", "P160022", "P160033", "P200004", "P160028", "P160015", "P160026" ], "registration_number": [ "", "1423537", "9681191", "3030733800", "3002807314", "3004035727", "3012494290", "3002714378", "3029871637", "3026007685", "3009077524", "3012502601", "3014579161", "3043226252", "3013517171", "1218058", "3003521780", "1921846", "3012972516", "3038259592", "3013826848", "3003537036", "3005621729", "3014572985", "1223925", "3006108746", "2112020", "1423662", "3008717264", "8020045", "3030446844", "3026976873", "3010317211", "3021559257", "9681860", "3004906872", "3010783192", "3020460367", "3010839093", "3030677", "3013596024", "3012104670", "3005906887", "3027815", "3015876", "3013557562", "3003800159", "3017422354", "3009886119", "3010030355", "3003867964", "1219103", "1317188", "1320894", "1720929", "1220908", "3013500228", "1930027", "3011823740", "3000126629", "3015997711", 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"device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }