{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "161421", "product_res_number": "Z-0776-2018", "event_date_initiated": "2018-01-03", "event_date_created": "2018-02-28", "recall_status": "Terminated", "event_date_terminated": "2019-11-14", "res_event_number": "79132", "product_code": "MHX", "k_numbers": [ "K102495", "K143057" ], "product_description": "Intellivue iX Information Center Software - All PIIC iX Surveillance stations including:\n866023 IntelliVue Info Center iX A.0\n866117 PIIC Classic Upgrade\n866389 IntelliVue Info Center iX B.0, C.0\n867141 IntelliVue Info Center iX B.0\n866025 IntelliVue Server IX A.0\n866118 Database Server Upgrade A.0", "code_info": "All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0", "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": "Kristen Phillips\n978-659-3000", "reason_for_recall": "Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.", "root_cause_description": "Software design", "action": "To avoid this issue, do not intentionally restart any surveillance stations that have been running normally since the new year. You may use the workflows described in attachment Alternative Workflows for PIIC iX to avoid operations that may cause the surveillance station to restart. When a patient is discharged, confirm that the patient is discharged.\n\nPhilips has initiated a correction to address this issue and will provide this software update to customers with affected devices at no charge. Software updates for PIIC iX A.0x and B.0x are expected to be available by January 8th.\nA Philips Healthcare representative will contact customers with affected devices to arrange for correction of the issue. Contact your local Philips representative if you have a question about any device affected by this issue.", "product_quantity": "20357", "distribution_pattern": "Domestic and Foreign", "openfda": { "k_number": [ "K191106", "K112190", "K242962", "K122439", "K053121", "K061993", "K051217", "K050742", "K113657", "K103646", "K150329", "K030431", "K191769", "K073203", "K223574", "K033365", "K132533", "K221879", "K240320", "K061379", "K101692", "K992929", "K070566", "K120173", "K213490", "K033694", "K060135", "K053484", "K073280", "K970445", "K232962", "K101067", "K253170", "K945385", "K150030", "K250349", "K123472", "K000517", "K120631", "K922210", "K130584", "K013427", "K043549", "K092970", "K062095", "K000815", "K033600", "K101521", "K052756", "K152407", "K921014", "K092680", "K153702", "K112637", "K052707", "K020290", "K000168", "K023674", "K020531", "K170514", "K102376", "K223531", "K043276", "K000882", "K223498", "K151027", "K002478", "K221616", "K090443", "K100040", "K200494", 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