{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "127391", "product_res_number": "Z-1746-2014", "event_date_initiated": "2014-05-22", "event_date_posted": "2014-06-10", "recall_status": "Terminated", "event_date_terminated": "2018-05-16", "res_event_number": "68349", "product_code": "MHX", "k_numbers": [ "K103646", "K113125" ], "product_description": "IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352", "code_info": "Serial numbers within the following ranges that have the MX40 interfaces: 00700001 - US01443745 and US014Z1301 - US014Z1431", "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": "Peter Ohanian\n800-722-9377", "reason_for_recall": "IntelliVue MX40 (part numbers 865350, 865352) with software revisions B.00 or B.01 may not resume alarming when the alarms are paused and the pause timer ends.", "root_cause_description": "Software design", "action": "On May 22, 2014, each affected customer was sent an Urgent Medical Device Correction notification/Field Safety Notice. The letter explains the problem, explains the action to be taken by the consumer, and the action planned by Philips. \n\nThe 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.\n\nThe correction will consist of a free of charge software upgrade.\n\n A Philips Healthcare representative will contact customers with affected devices to arrange for service. \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:\n\nThe following two items must be configured when using MX40 with the IntelliVue Information Center iX: \n1.\tUtilize the default state of Pause Alarms at Yellow only, which disables the ability to Pause/Suspend all Red level alarms\nUtilize the default state of Remote Suspend Alarms as Off, which disables the use of the Pause Alarms feature at the MX40 device", "product_quantity": "42,600", "distribution_pattern": "United States: Nationwide\nForeign Countries:\nGermany, Austria, Finland, Sweden, Australia, Qatar, Canada, Netherlands, New Zealand, Portugal, United Kingdom, Spain, Belgium, France, Switzerland, Norway, Czech Republic, Poland, Italy, Singapore, Denmark, Iceland, India, Saudi Arabia, Ireland, Oman, Bahrain, Japan, Israel, Malaysia, South Africa, \nTurkey, Thailand, Latvia, Bulgaria, Indonesia, Slovenia, United Arab Emirates, \nHong Kong, Aruba, Chile, Lebanon, Korea, Kuwait, Taiwan, Argentina, Hungary, Luxembourg, Mexico, Gabon", "openfda": { "k_number": [ "K053207", "K920445", "K173454", "K093788", "K113187", "K131223", "K210906", "K003248", "K123472", "K922974", "K252589", "K180017", "K134046", "K260656", "K152552", "K933624", "K071020", "K071426", "K002158", "K201941", "K250349", "K002478", "K042642", "K252726", "K062576", 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