{ "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": "86511", "product_res_number": "Z-0853-2010", "event_date_initiated": "2008-01-23", "event_date_posted": "2010-02-25", "recall_status": "Terminated", "event_date_terminated": "2010-10-22", "res_event_number": "53785", "product_code": "DXH", "k_numbers": [ "K020534", "K050951" ], "product_description": "Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. \n\nThe device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.", "code_info": "Serial number range affected is 3554 through 3798. Serial numbers 3554, 3559, 5375, 3579, 3584, 3586, 3587, 3594, 3615, 3655, 3664, 3669 ,3670, 3676, 3680, 3682, 3683, 3694, 3696, 3703, 3708, 3725, 3744 and 3798 have not yet been corrected.", "firm_fei_number": "3004198411", "recalling_firm": "Cybernet Systems Corp.", "address_1": "727 Airport Blvd", "city": "Ann Arbor", "state": "MI", "postal_code": "48108-1639", "additional_info_contact": "734-668-2567", "reason_for_recall": "A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.", "root_cause_description": "Component design/selection", "action": "The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices.\n\nContact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.", "product_quantity": "24", "distribution_pattern": "Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.", "openfda": { "k_number": [ "K183319", "K925535", "K173589", "K983026", "K142743", "K173248", "K780158", "K820828", "K032736", "K812755", "K220795", "K100383", "K811512", "K782076", "K964036", "K831092", "K901591", "K122184", "K932863", "K132206", "K772186", "K052767", "K854013", "K050951", "K834034", "K093976", "K941898", "K822955", "K012407", "K942586", "K882290", "K001091", "K912379", "K010436", "K803315", "K892370", "K801700", "K932859", "K915472", "K811758", "K920984", "K220350", "K840587", "K172801", 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"3010082909", "3011235999", "3008881376", "3003174284", "3012404027", "3021769057", "3014235520", "3014579161", "3000130829" ], "device_name": "Transmitters And Receivers, Electrocardiograph, Telephone", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2920", "device_class": "2" } } ] }