{ "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": "93077", "product_res_number": "Z-0322-2011", "event_date_initiated": "2010-07-16", "event_date_posted": "2010-11-08", "recall_status": "Terminated", "event_date_terminated": "2012-09-05", "res_event_number": "56255", "product_code": "MKJ", "k_numbers": [ "K051137" ], "product_description": "HeartStart MRx Defibrillator/Monitor\nModels: M3535A / M3536A / M3536J / M3536MC\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": "This action affects all customers who were shipped an MRx unit from 2/11/2004 through 06/25/2010", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "978-687-1501", "reason_for_recall": "Updated Instructions for Use- HeartStart MRx monitor/defibrillator. The update provides more detailed information on:\n\" Default ECG Lead Behavior\n\" Synchronized Cardioversion using External Paddles", "root_cause_description": "Labeling design", "action": "Philips issued an Urgent Voluntary Medical Device Correction notification/Field Safety Notice and an Instructions for Use Addendum on July 20, 2010, to affected customers. The Notice identified the product, the problem, and the action customers should take. In the USA, the notification sent to all affected customers via UPS and confirmation of delivery would be tracked. Outside the USA, Philips representatives in the affected geographies would manage their mailings locally. Customers were instructed to review the HeartStart MRx Instructions for Use addendum and keep a copy with their equipment - Instructions for Use. Additionally, they were instructed to insure that all users are fully trained on the MRx and, in particular, ensure that they review and understand have reviewed and understand the additional detail provided in the notification.\nFor questions regarding this recall call (800) 722-9377.", "product_quantity": "41,119 units", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: \nCANADA\nAFGHANISTAN\nALBANIA\nARGENTINA\nARUBA\nAUSTRALIA\nAUSTRIA\nAZERBAIJAN\nBAHRAIN\nBELGIUM\nBOSNIA&HERZEGOVINA\nBRAZIL\nBRUNEI DARUSSALAM\nBULGARIA\nCHILE\nCHINA\nCOLOMBIA\nCYPRUS\nCZECH REPUBLIC\nDENMARK\nECUADOR\nEGYPT\nESTONIA\nFINLAND\nFRANCE\nGERMANY\nGREECE\nGUADELOUPE\nHONG KONG\nHUNGARY\nICELAND\nINDIA\nINDONESIA\nIRELAND\nISRAEL\nITALY\nJAPAN\nJORDAN\nKENYA\nKUWAIT\nLATVIA\nLEBANON\nLIBYAN ARAB JAMAHIRI\nLITHUANIA\nLUXEMBOURG\nMACEDONIA\nMALAYSIA\nMEXICO\nMOROCCO\nNAMIBIA\nNETHERLANDS\nNETHERLANDS ANTILLES\nNEW CALEDONIA\nNEW ZEALAND\nNICARAGUA\nNORWAY\nOMAN\nPAKISTAN\nPALESTINE\nPANAMA\nPAPUA NEW GUINEA\nPERU\nPHILIPPINES\nPOLAND\nPORTUGAL\nPUERTO RICO\nQATAR\nREUNION\nROMANIA\nRUSSIA\nSAUDI ARABIA\nSERBIA&MONTE NEGRO\nSINGAPORE\nSLOVENIA\nSOUTH AFRICA\nSOUTH KOREA\nSPAIN\nSRI LANKA\nSWEDEN\nSWITZERLAND\nTAIWAN\nTHAILAND\nTRINIDAD AND TOBAGO\nTUNISIA\nTURKEY\nUGANDA\nUKRAINE\nUNITED ARAB EMIRATES\nUNITED KINGDOM\nVENEZUELA\nVIET NAM\nYEMEN", "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", 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"device_name": "Automated External Defibrillators (Non-Wearable)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5310", "device_class": "3" } } ] }