{ "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": "192066", "product_res_number": "Z-0813-2022", "event_date_initiated": "2022-01-20", "event_date_created": "2022-03-21", "recall_status": "Open, Classified", "res_event_number": "89616", "product_code": "KDI", "k_numbers": [ "K190793", "K200741" ], "product_description": "Outset Tablo Console\n\nModel Number: PN-0003000\nModel Number: PN-0006000", "code_info": "Model Numbers: PN-0003000\nUDI Codes: (01)00850001011112(11)200218;\nSerial 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Numbers: PN-0006000\nUDI Codes: (01)00850001011204(11)201203;\nSerial 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"firm_fei_number": "3010355846", "recalling_firm": "Outset Medical, Inc.", "address_1": "3052 Orchard Dr", "city": "San Jose", "state": "CA", "postal_code": "95134-2011", "additional_info_contact": "Jennifer Mascioli-Tudor\n669-231-8200", "reason_for_recall": "Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.", "root_cause_description": "Device Design", "action": "On 01/20/2022, the firm send a \"MEDICAL DEVICE FIELD ACTION\" Letter to customers informing them that Outset Medical is proactively replacing a component on the Talbo Hemodialysis consoles due to the possibility of heat-related damage that may occur to the Tablo device. Outset Medical has identified that Tablo Hemodialysis Systems manufactured between July 6, 2018 and November 24, 2021 require the component replacement. Outset is indicating that the replacement will be completed within the next twelve months during the next routine maintenance or at the next service call. Outset Field Service Engineers will coordinate completion of the replacement.\n\nCustomers are instructed to complete the acknowledgement form and promptly return to Outset Medical\n\nFor questions, contact Outset Customer Experience Team at 844-698-2256.", "product_quantity": "1,123 systems (PN-0003000) and 1,487 (PN-0006000)", "distribution_pattern": "U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY.", "openfda": { "k_number": [ "K926568", "K982926", "K021615", "K034064", "K160444", "K844790", "K023874", "K013733", "K252377", "K232776", "K992564", "K131935", "K811944", "K000028", "K211370", "K043244", "K193005", "K062922", "K123288", "K112314", "K926373", "K070222", "K203062", "K970446", "K051520", "K150708", "K062090", "K122343", "K000724", "K883407", "K830487", "K870724", "K911094", "K032356", 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"Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2" } } ] }