{ "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": 216 } }, "results": [ { "cfres_id": "209918", "product_res_number": "Z-0019-2025", "event_date_initiated": "2024-08-01", "event_date_posted": "2024-10-03", "recall_status": "Open, Classified", "res_event_number": "95294", "product_code": "KDI", "k_numbers": [ "K233335" ], "product_description": "Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.", "code_info": "UDI-DI: 00850001011112, 00850001011204. 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600667M, 601445M, 601446M, 601463M, 601476M, 601194M, 601197M, 601236M, 601237M, 601252M, 601302M, 601311M, 600108M, 600109M, 600119M, 600123M, 600629M, 600633M, 600634M, 600638M, 600665M, 601229M, 601316M, 601372M, 601412M, 601439M, 601448M, 601451M, 601458M, 601460M, 600871M, 600879M, 601766M, 601768M, 601770M, 600405M, 600407M, 600415M, 600420M, 600424M, 600932M, 600933M, 600938M, 600945M, 600735M, 600755M, 601061M, 601062M, 601184M, 601188M, 601189M, 602004M, 602005M, 602615M", "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": "669-231-8200", "reason_for_recall": "Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.", "root_cause_description": "Nonconforming Material/Component", "action": "On 8/1/24, field action notices were sent to customers who were asked to do the following:\n\nComponent replacement will be performed with routine maintenance and/or service to affected devices. To support component replacement, the device software may be upgraded, as needed. A firm's Field Service Engineer will coordinate this service with your staff to minimize device downtime.\n\nDisseminate this information to appropriate personnel within your facility for processing and distribution. This notice should be shared with any organization where the potentially affected devices have been transferred.\n\nIdentify and notify your home patients with affected devices of this component replacement.\n\nAccounts that have completed the firm's biomedical engineering training program and service their systems will receive additional information.\n\nComplete and return the response form via email to FieldActionAdvisory@OutsetMedical.com\n\nIf you have any questions regarding this notification contact the firm's Technical Support team (844-698-2256 or support@outsetmedical.com).", "product_quantity": "2,422", "distribution_pattern": "US: CA, NY, IL, MO, KY, AZ, PA, FL, GA, AK, NM, VA, NC, SC, OK, AL, MA, OH, MI, WA, ID, TX, TN, WY, IA, LA, NE, IN, AR, NV, WV, CO, NJ, MD, KS, UT, CT, MN, MS, WI, HI, DE, VT, MT, OR, ND.\n\nOUS: UAE", "openfda": { "k_number": [ "K861106", "K062090", "K981681", "K801479", "K853333", "K160881", "K952982", "K830595", "K231406", "K243874", "K170469", 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