{ "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": "140703", "product_res_number": "Z-0320-2016", "event_date_initiated": "2015-10-14", "event_date_posted": "2015-11-20", "recall_status": "Terminated", "event_date_terminated": "2018-09-13", "res_event_number": "72344", "product_code": "MKJ", "k_numbers": [ "K031187", "K040404", "K051134", "K061707", "K062233" ], "product_description": "Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. \nFor use for the termination of ventricular tachycardia and ventricular fibrillation.", "code_info": "Devices manufactured prior to June 4, 2015. Affected serial numbers range from US00100100 - US00587045.", "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": "800-722-9377", "reason_for_recall": "The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.", "root_cause_description": "Software design", "action": "On 10/14/2015, Philips sent an Urgent Field Safety Notice to each known affected customer. The Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. Philips will provide a software upgrade for M3535A (software version F.03.07 or higher) and M3536A (software version T.00.06 or higher) to correct this issue. A software upgrade will be provided free of charge for all affected products. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrades.\n\nPhilips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: \nAll MRx users should be informed that if the pattern appears, they can continue to use the device. Once the MRx is turned on, the pattern will disappear and the device will function normally in all monitoring and therapy modes.", "product_quantity": "81,161", "distribution_pattern": "Worldwide Distribution - US (nationwide) including Puerto Rico, and the countries of AFGHANISTAN, ALBANIA, ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA (local name: Hrvatska), CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GHANA, GREECE, GUADELOUPE, HONG KONG, Hungary, ICELAND, India, INDONESIA, ISLAMIC REPUBLIC OF IRAN, Iraq, IRELAND, ISRAEL, ITALY, JAPAN, Jordan, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LAOS, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACAU, MACEDONIA, MALAYSIA, MALTA, Mauritius, Mexico, MONGOLIA, MOROCCO, MOZAMBIQUE, Myanmar (Burma), NAMIBIA, NEPAL, NETHERLANDS, NETHERLANDS ANTILLES, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, State of Palestine, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH, AFRICA, SPAIN, SRI, LANKA, SWEDEN, SWITZERLAND, TAIWAN, UNITED REPUBLIC OF TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED, ARAB, EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, VIETNAM, and YEMEN", "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", 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"K000638", "K032421", "K883341", "K984286", "K014209", "K023854", "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", 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"3006108746", "1000524572", "3014579161", "1921846", "3001451571", "1000148701", "3008207730", "3012502601", "3015876" ], "device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }