{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "74994", "product_res_number": "Z-0034-2011", "event_date_initiated": "2008-11-21", "event_date_posted": "2010-10-08", "recall_status": "Terminated", "event_date_terminated": "2010-10-12", "res_event_number": "50215", "product_code": "DSI", "k_numbers": [ "K023698" ], "product_description": "The device's marketing brochure states: \"IntelliVue M3150 Information Center...Philips Medical Systems\".\n\nThe beige-colored PAS-210 external speakers can be identified by their use of DB15-to-3.5 mm mini-phone jack cable (Agispec-081Y-4 or Agispec-081-6) to connect to the rp5700 PC.\n\nIndicated for central monitoring of multiple adult, pediatric, and neonatal patients.", "code_info": "Serial numbers 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4810A04981, 4810A04982, 4810A04983, 4810A04984, 4810A05025, 4810A05026, 4810A05027, 4810A05028, 4810A05009, and 4810A05012.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Customer Care Service Center\n800-722-9377", "reason_for_recall": "Potential for Internal Sound Amplifier to malfunction which could delay treatment.", "root_cause_description": "Component change control", "action": "On 11/20/08, Philips began sending the URGENT-Medical Device Correction letter to their consignees via e-mails. On 11/21/08, the firm sent out the recall letter via United State Postal Service.\n\nThe letter states the affected device as Philips IntelliVue Information Centers, running on the HP rp5700 PC platform equipped with an active speaker solutions using a DB-15 to 3.5 mm cable set.\n\nThe consignees are advised to ensure that the audible alarm system is clear, free of noise and distortion and adjustable to different sound levels which is explained in p. 5-47 \"Adjusting Alarm Tone Volume\" of IntelliVue of the Instruction for Use, Release K Manual, supplied with the hardware, Philips Part Number 453564062301.\n\nConsignees can call Philips Healthcare Customer Care Service Center at 1-800-722-9377, #3, #1 and reference FCO 99862012.", "product_quantity": "424 units in US.", "distribution_pattern": "Nationwide Distribution", "openfda": { "k_number": [ "K900246", "K012461", "K142180", "K954852", "K924672", "K852270", "K935846", "K962827", "K952912", "K952054", "K883410", "K001120", 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"K913576", "K853669", "K912744", "K852514", "K970358", "K803208", "K895266", "K003246", "K993757", "K972502", "K946306", "K820438", "K850136", "K152491", "K760884", "K132407", "K143359", "K955743", "K192732", "K033305", "K834211", "K173170" ], "registration_number": [ "3009077524", "3003589956", "3001570235", "3005783425", "3004574071", "3009499478", "3007305624", "3013783488", "3009380063", "3010120148", "3010698831", "3009490946", "3008642652", "3022298579", "9611031", "3015328411", "3012238587", "9681377", "3016618143", "3022123357", "3043543260", "3008973940", "3018783526", "3012552532", "3016812424", "3009673645", "3010381606", "3009883402", "8030229", "3010120135", "2221819", "1218950", "3008729547", "3013679558", "1651104", "3017942784", "3016852448", "3013889955", "1066270", "1316463", "3013501110", "2080783", "3010390468", "3011937459", "2028530", "2182208", "3003584029", "3005737664", "1037137", "1033601", "3007836437", "3000126629", "3008494315", "1930027", "3013791928", 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"3007305624", "3013783488", "3009380063", "3010120148", "3010698831", "3009490946", "3008642652", "3015328411", "3022298579", "3012238587", "3016618143", "3008377825", "3043543260", "3008973940", "3018783526", "3012552532", "3016812424", "3009673645", "3010381606", "3009883402", "3010120135", "1000300598", "2221819", "1218950", "3008729547", "3013679558", "3017942784", "3016852448", "3013889955", "3003513129", "1000520785", "1316463", "1000127185", "3013501110", "2080783", "3002806783", "3010390468", "3011937459", "2182208", "3003584029", "3005737664", "1037137", "1000125122", "1033601", "3007836437", "3000126629", "1930027", "3000215024", "3013791928", "3011120183", "3013896610", "3008363989", "3010082909", "3010032903", "3011353843", "3023164", "3010830833", "3016674095", "3031162043", "3008716327", "3006979678", "3002807019", "3007734888", "3009156722", "3009607734", "3008483389", "3009959868", "3029904429", "3008773647", "1219324", "3009831876", "1527715", "3010041430", "3004593495", "1000115656", "3004188066", "3002807167", "3007770164", "3015181391", "3019388613", "3010536822", "3007413079", "3004977335", "3021769057", "3005877899", "3010157426", "3012606445", "3007048291", "3010112812", "3000957797", "3004185781", "3023272766", "3004009431", "3003263092", "3002807576", "3010863450", "3012359877", "3016701404", "3012528160", "3013596024", "3014541700", "3007208829", "3007603826", "3002737156", "3013500228", "3032109181", "1000122786", "1000425315", "2017865", "3004415095", "3010703925", "3003971136" ], "device_name": "Detector And Alarm, Arrhythmia", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1025", "device_class": "2" } } ] }