{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "184676", "product_res_number": "Z-0544-2021", "event_date_initiated": "2020-11-18", "event_date_created": "2020-12-08", "recall_status": "Terminated", "event_date_terminated": "2021-07-22", "res_event_number": "86848", "product_code": "DSI", "k_numbers": [ "K082633" ], "product_description": "Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.", "code_info": "Serial Numbers: US: DE73607502 DE73607498  OUS:  System Serial Number DE95038935 DE73608191 DE73608209 DE73601727  DE73604240 DE73601547 DE73601596 DE73604182 DE83617535 DE73608259 DE83617500 DE83617522 DE73601651", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.", "root_cause_description": "Process control", "action": "Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take:\n\nPhilips is asking users to follow the Action to be Taken by Customer/User section of the FSN:\nAffected products may continue to be used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the Speaker Malfunct. INOP at power-up.\nIf you experience this INOP or there is no sound from your X2 / MP2 speaker while it is not connected to another audible alarm annunciation system, remove the device from use and contact your local Philips service representative Philips representative or Philips Customer Support at 1-800-722-9377\nPlease complete the attached Reply Card and return it to Philips as soon as possible.\n\nPhilips will replace affected speaker assemblies free of charge. \nA Philips Healthcare representative will contact you to arrange for the replacement of the speaker assembly in the listed affected devices.", "product_quantity": "16 total: 2 units US ; 14 OUS", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.", "openfda": { "k_number": [ "K863724", "K083517", "K897074", "K802312", "K920154", "K971131", "K151269", "K903704", "K896967", "K946306", "K830306", "K121197", 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