{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "199059", "product_res_number": "Z-1355-2023", "event_date_initiated": "2021-10-21", "event_date_posted": "2023-04-10", "recall_status": "Open, Classified", "res_event_number": "91853", "product_code": "JAA", "k_numbers": [ "K163210", "K203087" ], "product_description": "CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031", "code_info": "GTIN: (01)00884838076747 (Model 709030), (01)00884838101456 (Model 709031;\nSerial Numbers: 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"firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Customer Care Solution Center\n800-722-9377", "reason_for_recall": "If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.", "root_cause_description": "Device Design", "action": "An IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the CombiDiagnost R90 system.\n\nThe system may experience a short circuit of the Electromagnetic Interference (EMI) filter or UA/UB board, with a potential for smoke and/or a popping sound coming from the Main cabinet. If a user sees or smells smoke or hears a popping noise coming from the M-cabinet, immediately remove power to the room (main circuit breaker) and remove the patient. Stop using the system for further examinations. \n\nAn IMPORTANT PRODUCT NOTICE dated 10/21/21 was sent to customers with the ProxiDiagnost N90.\nCustomers may encounter one or both issues:\n1: Potential component damage due to short circuit, leading to smoke, or a popping noise coming from the M-cabinet. \n2: Potential table stop due to a broken tabletop cable. \n\nAn IMPORTANT PRODUCT NOTICE dated 11/15/22 was sent to customers with the ProxiDiagnost N90 1.1 for the same issues as the ProxiDiagnost N90 letter dated 10/21/21.\n\nAn URGENT Medical Device Correction Notification Update for the CombiDiagnost R90 and ProxiDiagnost N90 dated February 2023 was sent to customers.\n\nFor component damage due to short circuit, if a user observes fire in the M-cabinet, sees or smells smoke, or hears a popping noise coming from the M-cabinet: Contact Customer Care Solutions Center (1-800-722-9377). Reference FCO70900054 (CombiDiagnost R90), FCO70600105 (ProxiDiagnost N90 1.0), or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site. \nFor ProxiDiagnost N90 table stop due to a broken tabletop cable, if the table is not tilting or braking as expected: Contact Customer Care Solutions Center (1-800-722-9377). Reference FCO70600105 (ProxiDiagnost N90 and N90 1.0) or FCO70600108 (ProxiDiagnost N90 1.1) to arrange for a Philips Field Service Engineer to visit your site to inspect and fix the cable.\n\nUPDATED 7/27/2023: Scope of affected products was increased. Additional consignees were notifie", "product_quantity": "512 units", "distribution_pattern": "US Nationwide. Global Distribution.", "openfda": { "k_number": [ "K920720", "K101491", "K251650", "K827489", "K874901", "K081582", "K142341", "K810189", "K964322", "K834286", "K950781", "K922274", "K901405", "K933299", "K923137", "K800639", "K840134", "K022899", "K893476", "K950971", "K081621", "K840364", "K952456", "K982319", "K963617", "K893475", "K161019", "K953113", "K200965", "K833641", "K895394", "K942019", "K843920", "K810364", "K912896", "K052610", "K922013", "K961193", "K992603", "K203428", "K942841", "K150306", "K951261", "K792225", "K840225", "K770337", "K884317", "K020055", "K871743", "K915405", "K954590", "K232526", "K010772", "K811094", "K873985", "K914525", "K920550", "K191310", "K972442", "K173395", "K901323", "K110785", "K904986", "K022565", "K890745", "K771298", "K943447", "K191877", "K950631", "K024012", "K923585", "K905111", "K902927", "K080859", "K833237", "K933791", "K212890", "K943805", "K926064", "K920721", "K993038", "K882175", "K840621", "K884028", "K833230", "K955687", 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