{ "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": "160148", "product_res_number": "Z-0348-2018", "event_date_initiated": "2017-07-17", "event_date_created": "2018-01-14", "recall_status": "Terminated", "event_date_terminated": "2018-07-12", "res_event_number": "78702", "product_code": "MKJ", "k_numbers": [ "K031187", "K040404", "K051134", "K061707", "K062233" ], "product_description": "ECG Out Cable - Heartstart MRx\nM1783A/M5526A 12-pin Sync cables\nAll units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641.\nManufactured - September 4, 2002 October 8, 2014", "code_info": "M1783A/M5526A 12-pin Sync cables  All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641", "firm_fei_number": "1218950", "recalling_firm": "Philips Electronics North America Corporation", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Tom Fallon\n978-659-3000", "reason_for_recall": "Issue with ECG out cables. When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable or ECG out cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs):\n\n\"\tOn the HeartStart MRx and HeartStart XL, EFT noise may be misinterpreted as an R-wave.\n\"\tOn the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. \n\n*Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.", "root_cause_description": "Device Design", "action": "Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent\nMedical Device Correction notification/Field Safety Notice:\n\nCustomers should remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the attached reply form, which should be returned to Philips. Customers should retain a copy of the reply form.\n\nThe customer should follow the Instructions for Use that describe the recommended approach for performing cardioversion with the XL+ and MRx monitor/defibrillators. The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy; this is the preferred source of an ECG waveform for synchronization.", "product_quantity": "15811", "distribution_pattern": "1067 US customers\n163 Canada, 917 International", "openfda": { "k_number": [ "K102496", "K010214", "K011901", "K130684", "K000638", "K110742", "K003565", "K984582", "K896919", "K002232", "K150055", "K990106", "K131550", "K973486", "K133659", "K051632", "K883341", "K020984", "K041883", "K932028", "K991007", "K052316", "K870622", "K103186", "K991910", "K955854", "K965117", "K934692", "K020743", "K010207", "K980857", "K131525", "K142430", "K981737", "K002806", "K014157", "K952101", "K063375", "K022929", "K142709", "K111693", "K011541", "K051475", "K981802", "K060934", "K892005", "K982992", "K012030", "K010257", "K942344", "K925936", "K012766", "K002445", "K013425", "K040479", "K062970", "K942850", "K133441", "K072233", 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"K993533", "K080903", "K023854", "K110361", "K113787", "K971148", "K970391", "K110154", "K041459", "K033642", "K072923", "K062177", "K072812", "K122600", "K141795", "K020203", "K040056", "K042417", "K081828", "K972418", "K955628", "K100565", "K033474", "K993072", "K970741", "K042404", "K092391", "K954504", "K062537", "K955923", "K892065", "K960329", "K932931", "K030898", "K002079", "K011388", "K954609", "K022732", "K091943", "K081371", "K091548", "K131494", "K003228", "K020715", "K972241", "K982710", "K860676", "K883344", "K082090", "K042007", "K142803", "K993036", "K031987", "K022210", "K090989", "K041892", "K111594", "K010918", "K033896", "K120536", "K020288", "K060559", "K141774", "K081081", "K062233", "K882067", "K935922", "K110168", "K072596", "K953204", "K141231", "K021168", "K123881", "K143714", "K112761", "K133484", "K883584", "K982025" ], "pma_number": [ "P160034", "P210015", "P200004", "P170018", "P190013", "P160022", "P180028", "P190007", "P200007", "P160008", "P200005", "P160012", "P160015", "P160026", "P160028", "P160032", "P160033" ], "registration_number": [ "", "3013826848", "3010703925", "8020045", "1219103", "3030446844", "3005621729", "3020460367", "3004906872", "3012494290", "3012502601", "3012607778", "3015134086", "3010030355", "1720929", "3021559257", "3026976873", "3012104670", "3013500228", "1320894", "2112020", "3009077524", "3015876", "3014579161", "3029871637", "3030677", "3002807314", "3003537036", "1423537", "3010317211", "1921846", "2132111", "3027815", "1220908", "9681191", "3006108746", "3004123209", "3008717264", "3011823740", "3017422354", "3030733800", "3015997711", "3005906887", "3004035727", "1423662", "3038259592", "3003800159", "1930027", "3009886119", "3013557562", "3003867964", "3010839093", "9681860", "3010783192", "3012972516", "3026007685", "1223925", "3013596024", "3043226252", "3003521780", "1317188", "3002714378", "3007029079", "3000126629", "3013517171", "3014572985", "1218058" ], "fei_number": [ "1000524572", "", 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"regulation_number": "870.5310", "device_class": "3" } } ] }