{ "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": "124617", "product_res_number": "Z-0593-2014", "event_date_initiated": "2013-06-07", "event_date_posted": "2013-12-27", "recall_status": "Terminated", "event_date_terminated": "2017-03-22", "res_event_number": "67052", "product_code": "MKJ", "k_numbers": [ "K051134" ], "product_description": "Philips HeartStart MRx Monitor/Defibrillator\r\nModels: M3536A Options A20 - A27, HeartStart MRx ALS\r\nMonitor (Grey)\r\n\r\nThe HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician", "code_info": "Serial numbers: US00558442 - US00558461\tUS00561519 US00558531 - US00558532\tUS00561578 US00558615\t US00562454 US00558758 - US00558759\tUS00562504 - US00562527 US00560165 - US00560166\tUS00562640 - US00562641 US00560738 - US00560739\tUS00562832 US00560740 - US00560745\tUS00563125 US00560872\t US00563231 - US00563243 US00560909\t US00564032 US00561068\t US00564177 US00561209\t US00564409 US00561447 - US00561452\tUS00564793", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems, Inc.", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "978-687-1501", "reason_for_recall": "Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10", "root_cause_description": "Labeling Change Control", "action": "Philips sent a Customer Information Letter dated June 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.\r\n\r\nDuring an EI of the firm, the firm had not reported the correction to FDA.\r\nThe Customer Information letter informs the customers what the behavior is and under what circumstances. The correction consisted of a replacement label that was provided free of charge to all units affected by this issue. Philips Healthcare representatives have been contact customers with affected devices to arrange for installation of the replacement label.\r\n\r\nTo correct this issue, Philips will replace the label free of charge. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the replacement label. This issue does not affect current product shipments.\r\nI\r\nf you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377.\r\nPhilips apologizes for any inconvenience caused by this problem.", "product_quantity": "93 units", "distribution_pattern": "Worldwide Distribution - US Distribution including the states of IN, MS, TX and VA., and the countries of DENMARK, FRANCE, GERMANY, SPAIN and SWITZERLAND.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", "K063510", "K041067", "K111693", "K130684", "K010214", "K063119", "K091265", "K123881", "K962359", "K932931", "K062177", "K942850", 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"K993533", "K051475" ], "pma_number": [ "P160032", "P210015", "P200007", "P160033", "P160015", "P160022", "P160012", "P160008", "P190007", "P200004", "P190013", "P200005", "P160026", "P170018", "P160028", "P160034", "P180028" ], "registration_number": [ "3030733800", "", "3026007685", "3003867964", "3013517171", "2132111", "1220908", "3020460367", "3010783192", "3003800159", "3010703925", "3012494290", "2112020", "3010839093", "3015997711", "1720929", "3004123209", "3017422354", "3004035727", "3026976873", "3005906887", "1317188", "3015134086", "3012104670", "3000126629", "3043226252", "3013500228", "1219103", "3004906872", "3003537036", "3014572985", "1423537", "3011823740", "1423662", "3021559257", "3010030355", "3012972516", "3005621729", "3038259592", "3029871637", "3007029079", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3012607778", "3030446844", "3030677", "1218058", "3027815", "3002807314", "9681860", "3009077524", "9681191", "1320894", "3013557562", 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"1000148701", "3008207730", "3012502601", "3015876" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }