{ "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": "74699", "product_res_number": "Z-0817-2009", "event_date_initiated": "2008-10-22", "event_date_posted": "2009-01-13", "recall_status": "Terminated", "event_date_terminated": "2017-03-24", "res_event_number": "50088", "product_code": "DSI", "k_numbers": [ "K082633" ], "product_description": "Philips M8000-64100 Table Mount \n\nShipped standard with all IntelliVue Patient Monitors MP40-70, Gas Modules Gl and G5 and certain options of the IntelliVue Patient Monitors MP5 MPST and MP20/30.\n\nProduct shipped between 6/03/08 and 9/12/08 as follows:\nM1013A IntelliVue G1 Gas Module\nM1019A IntelliVue GS Gas Module\nM8001A option E22 Quick release mount for IntelliVue MP20\nM8002A option E22 Quick release mount for IntelliVue MP30\nM8003A IntelliVue MP40\nM8004A IntelliVue MPSO\nM8005A IntelliVue MP60\nM8007A IntelliVue MP70\nM8105A option E22 IntelliVue MP5 Quick Release Mount\nM8105AT option E22 IntelliVue MPST Quick Release Mount\nM8040A option U02 U02 Table top mount kit\nM8040A option E22 Quick release kit for MP20MP30\n\nThe Philips IntelliVue Patient Monitors are intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates in hospital environments. The MP2, X2, MP5, MP20, MP30, MP40, and MP50 are additionally intended for use in transport situations within hospital environments.", "code_info": "Product shipped between 6/03/08 and 9/12/08 as follows: M1013A IntelliVue G1 Gas Module M1019A IntelliVue GS Gas Module M8001A option E22 Quick release mount for IntelliVue MP20 M8002A option E22 Quick release mount for IntelliVue MP30 M8003A IntelliVue MP40 M8004A IntelliVue MPSO M8005A IntelliVue MP60 M8007A IntelliVue MP70 M8105A option E22 IntelliVue MP5 Quick Release Mount M8105AT option E22 IntelliVue MPST Quick Release Mount M8040A option U02 U02 Table top mount kit  M8040A option E22 Quick release kit for MP20MP30  A list of S/N's can be obtained fromthe recalling firm.", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "978-687-1501", "reason_for_recall": "Table Mounts assembled with incorrect length hardware may fall", "root_cause_description": "Process control", "action": "Philips issued an \"Urgent Medical Device Correction\" notification to all potentially affected customers on 10/22/08 via UPS for the US customers. The letter mailed to customers outside the US by Philips' regulatory contacts in each country via a tracked method.\nThe letter informs customers of the problem and gives instructions on how to identify affected table mounts. Field Service Engineers will be dispatched to each customer site to inspect each Table Mount. If customers detect any sign of a loose connection between the monitor and the mounting plate while they are awaiting the Field Service Engineer, they are instructed to make sure that the monitor is not in a position to fall. They are asked to disconnect the monitor from the table mount. For additional information, contact Philips Medical Systems at 1-978-687-1501.", "product_quantity": "14,292 units", "distribution_pattern": "Nationwide\nCanada\nForeign: Argentina, Aruba, Australia, Austria, Bahain, Bangladesh, Belgium, Bosnia, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Egypt, Finland, France, Gabon, Germany, Great Britain, Greece, Hong Kong, Iceland, India, Iraq, Ireland , Italy, Japan, Korea, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Namibia, Netherlands, Norway, Peru, Philippines, Poland,Portugal, Russia, Saudia Arabia, Singapore, Slovenia\nSouth Africa, Spain.,. Srilinka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Uganda, UAE, Uzbekistan, Venezuela, Vietnam, and Zambia", "openfda": { "k_number": [ "K863724", "K083517", "K897074", "K802312", "K920154", "K971131", "K151269", "K903704", "K896967", "K946306", "K830306", "K121197", "K844791", "K852270", "K822616", "K972502", "K910109", "K952417", "K896771", "K182532", "K091927", "K050605", "K101639", "K011824", "K850897", "K924672", "K803208", "K945944", "K771374", "K802900", "K910808", "K032858", "K991773", "K911835", "K142352", "K032370", "K840622", "K860834", "K864506", "K864505", "K830407", "K852207", "K820856", "K955023", "K962291", "K952912", "K900385", "K970358", "K885256", "K090834", "K841083", "K891148", "K865032", "K152550", "K822030", "K935877", "K912744", "K790287", "K802033", "K872497", "K832693", "K243349", "K142180", "K823585", "K071805", "K760368", "K781911", "K864149", "K942058", "K935732", "K990093", "K894858", "K980429", "K820438", "K881905", "K903514", "K931716", "K124060", 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"3008642652", "3013896610", "3016701404", "3000126629", "3010830833", "3008363989", "3008483389", "1000122786", "3003589956", "3011937459", "3015181391", "3009490946", "1000425315", "3007603826", "3009077524", "3002806783", "3002807739", "3000215024", "3012238587", "3010157426", "3004977335", "3008716327", "2221819", "3010082909", "2017865", "3018783526", "3013596024", "3010041430", "3015328411", "3007208829", "3007836437", "3004009431", "3010863450", "3013679558", "3000957797", "1033601", "3004415095", "3008729547", "3004188066", "3002807576", "3012552532", "3004185781", "3004574071", "3013783488", "2182208", "3009499478", "3008773647", "3003263092", "3009673645", "1000127185", "3003584029", "2080783", "3016812424", "3013791928", "3011353843", "3010698831", "3013501110", "3008973940", "3016852448" ], "device_name": "Detector And Alarm, Arrhythmia", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }