{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "160142", "product_res_number": "Z-0278-2018", "event_date_initiated": "2017-09-28", "event_date_created": "2017-12-21", "recall_status": "Terminated", "event_date_terminated": "2018-10-12", "res_event_number": "78698", "product_code": "MSX", "k_numbers": [ "K031187", "K040404", "K051134", "K061707", "K062233", "K063375" ], "product_description": "Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator", "code_info": "20 units - US00597060, US00597964, US00598048, US00598210, US00598784, US00599490, US00599495, US00599508, US00599572, US00599613, US00599615, US00599623, US00599726, US00600362, US00600363, US00600370, US00600422, US00600423, US00600438, US00600483", "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": "Gary Gilliam\n978-659-3000", "reason_for_recall": "Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or CO2 waveform (capnogram).", "root_cause_description": "Nonconforming Material/Component", "action": "The Philips 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. 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