{ "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": 1 } }, "results": [ { "cfres_id": "168916", "product_res_number": "Z-0592-2019", "event_date_initiated": "2018-10-10", "event_date_created": "2018-12-10", "recall_status": "Open, Classified", "res_event_number": "81531", "product_code": "DSI", "k_numbers": [ "K113125" ], "product_description": "IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.", "code_info": "All devices manufactured or repaired from 21-FEB-2017 to 22-AUG -2018. (Serial numbers included as an attachment; too many to list.)", "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": "Philips Customer Support\n800-722-9377", "reason_for_recall": "A problem has been detected in the Philips IntelliVue MX4O that, if it were to occur, could affect the\nperformance of the equipment. The volume of the MX4O speaker in these devices may be diminished or not audible above 4,500 feet when operating in Monitor Mode. These devices may\nintermittently exhibit Speaker Malfunct INOP messages after the Power On\nSelf-Test.\nThe issue is only apparent when the device is being used in Monitor Mode at an\naltitude of greater than 4,500 feet.", "root_cause_description": "Vendor change control", "action": "On November 9, 2018, the firm notified customers of the issue via Customer Information Letters. The letter discussed the product problem. \n\nCustomers are asked to confirm speaker behavior. It is recommended that the clinical user reboot the MX40 prior to entering\nMonitoring Mode to confirm proper operation of the speaker. Customers are also asked to complete the attached Reply Card and return to Philips as soon as possible. \n\nThe firm will replace affected devices used at above 4,500 feet (1,372 meters).\n\nIf you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377.", "product_quantity": "35469 units", "distribution_pattern": "US Nationwide distribution.", "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", 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"3019388613", "3009490946", "3003263092", "1000125122", "3013501110", "3013596024", "3003971136", "3003513129" ], "device_name": "Detector And Alarm, Arrhythmia", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }