{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "172393", "product_res_number": "Z-1692-2019", "event_date_initiated": "2019-03-28", "event_date_created": "2019-06-01", "recall_status": "Open, Classified", "res_event_number": "82696", "product_code": "DSI", "k_numbers": [ "K113125" ], "product_description": "IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.", "code_info": "All revision B.X versions are affected.", "firm_fei_number": "1218950", "recalling_firm": "Philips North America, LLC", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "800-722-9377", "reason_for_recall": "The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .", "root_cause_description": "Software design", "action": "On March 28, 2019, Philips Healthcare distributed URGENT MEDICAL DEVICE RECALL notices (FSN 86201863A) dated March 22, 2019 to customers via courier service. \n\nActions To Be Taken by Customer/User at the time was as follows:\n- MX4O monitors can continue to be used while awaiting a software upgrade.\n\n- Customers should maintain an adequate supply of fully charged batteries given\nthe approximately 25% increased power consumption. Switch to continuous or manual SO2 measurements if your unit is using automatic measurement mode.\n\nOn April 24, 2019, Philips Healthcare distributed UPDATE URGENT MEDICAL DEVICE RECALL notices (FSN86201863B) dated April 16, 2019 to customers via courier service. \n\nActions To Be Taken by Customer/User is currently as follows:\nUntil you have upgraded the software on your MX4Os, replace your batteries\nevery 8 hours, unless you are using continuous monitoring mode and Sp02\nmonitoring with AA batteries, in which case replacement should be done every\n2 hours.\n\nPhilips Healthcare will release a software upgrade, which will correct this\nproblem. Philips will contact you to arrange for software correction.\n\nIf you need any further information or support concerning this issue please\ncontact your local Philips representative or Philips Customer Support at 1-800-\nSUPPORT 722-9377.", "distribution_pattern": "Worldwide distribution - US Nationwide and to 71 countries.", "openfda": { "k_number": [ "K860078", "K860834", "K980186", "K830029", "K913576", "K974792", "K830163", "K891148", "K071889", "K182532", "K830306", "K982697", "K895266", "K803282", "K012336", "K153473", "K864506", "K071655", "K844791", "K880505", "K942147", "K012241", "K082633", "K970348", "K152550", "K974698", "K781911", "K020550", "K960884", "K896862", "K011824", "K053263", "K944350", "K062976", "K151681", "K012461", "K781845", "K152491", "K231276", "K900246", "K873533", "K920743", "K173969", "K000822", "K961165", "K844464", "K970585", "K843731", "K952912", "K983980", "K955023", "K772360", "K920790", "K952885", "K910929", "K001359", "K822616", "K843503", 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"3013596024", "3003971136", "3003513129" ], "device_name": "Detector And Alarm, Arrhythmia", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }