{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124584", "product_res_number": "Z-0613-2014", "event_date_initiated": "2013-04-10", "event_date_posted": "2013-12-31", "recall_status": "Terminated", "event_date_terminated": "2017-04-13", "res_event_number": "67035", "product_code": "MKJ", "k_numbers": [ "K051134" ], "product_description": "Philips HeartStart MRx Monitor/Defibrillator\nModels: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6\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 ranging:  From US00100100 to US00210461", "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": "Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and", "root_cause_description": "Environmental control", "action": "Philips issued a Medical Device Correction letter April 2013 to all affected customers along with an IFU Addendum titled, HeartStart MRx Electromagnetic Compatibility. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the condition could be avoided by operating the device on external AC or external DC power. Customers were instructed to follow the device instructions when using battery power to minimize or eliminate potential interference from other RF sources. Customers with questions were instructed to contact their local Philips representative.\nFor questions regarding this recall call 978-687-1501.", "product_quantity": "64,972", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and Internationally to the following countries:\nAFGHANISTAN\nALBANIA\nARGENTINA\nARUBA\nAUSTRALIA\nAUSTRIA\nAZERBAIJAN\nBAHRAIN\nBANGLADESH\nBELGIUM\nBOLIVIA\nBOSNIA AND HERZEGOWINA\nBRAZIL\nBRUNEI DARUSSALAM\nBULGARIA\nCAMBODIA\nCANADA\nCHILE\nCHINA\nCOLOMBIA\nCOSTA RICA\nCROATIA (local name: Hrvatska)\nCYPRUS\nCZECH REPUBLIC\nDENMARK\nECUADOR\nEGYPT\nEL SALVADOR\nESTONIA\nETHIOPIA\nFINLAND\nFRANCE\nGERMANY\nGREECE\nGUADELOUPE\nHONG KONG\nICELAND\nINDIA\nINDONESIA\nIRAQ\nIRELAND\nISRAEL\nITALY\nJAPAN\nJORDAN\nKAZAKHSTAN\nKENYA\nKOREA, REPUBLIC OF\nKUWAIT\nLAOS\nLATVIA\nLEBANON\nLIBYAN ARAB JAMAHIRIYA\nLITHUANIA\nLUXEMBOURG\nMACAU\nMACEDONIA\nMALAYSIA\nMALTA\nMEXICO\nMONGOLIA\nMOROCCO\nNAMIBIA\nNEPAL\nNETHERLANDS\nNETHERLANDS ANTILLES\nNEW CALEDONIA\nNEW ZEALAND\nNICARAGUA\nNIGERIA\nNORWAY\nOMAN\nPAKISTAN\nPALESTINE\nPANAMA\nPAPUA NEW GUINEA\nPARAGUAY\nPERU\nPHILIPPINES\nPOLAND\nPORTUGAL\nPUERTO RICO\nQATAR\nREUNION\nROMANIA\nRUSSIAN FEDERATION\nSAUDI ARABIA\nSERBIA\nSINGAPORE\nSLOVENIA\nSOUTH AFRICA\nSPAIN\nSRI LANKA\nSWEDEN\nSWITZERLAND\nTAIWAN, PROVINCE OF CHINA\nTANZANIA, UNITED REPUBLIC OF\nTHAILAND\nTRINIDAD AND TOBAGO\nTUNISIA\nTURKEY\nTURKMENISTAN\nUGANDA\nUKRAINE\nUNITED ARAB EMIRATES\nUNITED KINGDOM\nUZBEKISTAN\nVENEZUELA\nVIET NAM\nYEMEN", "openfda": { "k_number": [ "K012766", "K072233", "K150198", "K991556", "K060559", "K091265", "K071025", "K111693", "K955890", "K110154", "K870622", "K932931", "K000638", "K942344", "K102972", "K020984", "K954609", "K972418", "K954504", "K142803", "K141774", "K073716", "K955882", "K082937", "K926172", "K003819", "K002806", "K091561", "K091943", "K883584", "K072596", "K070455", "K133659", "K991910", "K970741", "K022732", "K984286", "K110526", "K120406", "K011388", "K080232", 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