{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "119750", "product_res_number": "Z-1780-2013", "event_date_initiated": "2013-07-08", "event_date_posted": "2013-07-20", "recall_status": "Terminated", "event_date_terminated": "2017-05-17", "res_event_number": "65622", "product_code": "MHX", "k_numbers": [ "K041741" ], "product_description": "Radiohead Access Point 1.4 GHz Radiohead Access Point \nFirmware versions: C.00.04 & C.00.05 \nPart Number: 989803171211\n\nProduct Usage:\nIntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 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. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.", "code_info": "Serial numbers ranging from: US12700465 to US20823366", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "978-687-1501", "reason_for_recall": "IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several\nminutes impacting wireless connectivity", "root_cause_description": "Software Design Change", "action": "Philips sent an Urgent Medical Device Correction letter dated July 2013 to affected customers. The letter informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer. Philips will perform a firmware upgrade (version C.00..07 for all affected customers at no cost. Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice.\nIf you need any further information or support concerning this issue, please contact Philips Customer Support at 1-800-722-9377", "product_quantity": "20105 units", "distribution_pattern": "USA Nationwide Distribution", "openfda": { "k_number": [ "K073203", "K113045", "K945134", "K033957", "K102562", "K090443", "K933624", "K001268", "K101692", "K132533", "K110622", "K130208", "K223531", "K122146", "K201764", "K923054", "K011918", "K003243", "K073462", "K080342", "K152407", "K121367", "K103134", "K231477", "K993608", "K251702", "K060223", "K053484", "K014261", "K962424", "K073280", "K153448", "K014213", "K033694", "K001664", "K051367", "K213799", "K191323", "K093268", "K133576", "K000815", "K123556", "K151027", "K170514", "K171901", "K080157", "K922974", "K002478", "K120598", "K181831", "K021325", "K030657", "K030038", 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