{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "198994", "product_res_number": "Z-1351-2023", "event_date_initiated": "2023-01-24", "event_date_posted": "2023-04-07", "recall_status": "Open, Classified", "res_event_number": "91844", "product_code": "FIP", "k_numbers": [ "K190793", "K211370" ], "product_description": "Outset Tablo\n\nModel Numbers (REF):\nPN-0006000\nPN-0007001\n\nTablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.", "code_info": "Model Numbers:\nPN-0006000\nPN-0007001\nUDI-DI Code: 00850001011204\n\nSerial Numbers for PN-00060000\n600102M\n600185M\n600226M\n600229M\n600241M\n600251M\n600307M\n600383M\n600430M\n600554M\n600668M\n600684M\n600741M\n600742M\n600747M\n600757M\n600774M\n600815M\n600816M\n600817M\n600826M\n600828M\n600829M\n600856M\n600858M\n600867M\n600869M\n600875M\n600899M\n600904M\n600925M\n600932M\n600947M\n600954M\n600964M\n600974M\n600981M\n600983M\n600987M\n600988M\n601051M\n601052M\n601053M\n601055M\n601061M\n601069M\n601071M\n601073M\n601074M\n601078M\n601079M\n601083M\n601087M\n601091M\n601092M\n601093M\n601094M\n601097M\n601101M\n601103M\n601104M\n601106M\n601111M\n601112M\n601113M\n601118M\n601119M\n601120M\n601124M\n601125M\n601126M\n601127M\n601128M\n601129M\n601130M\n601131M\n601132M\n601135M\n601136M\n601137M\n601138M\n601139M\n601140M\n601141M\n601142M\n601143M\n601144M\n601145M\n601146M\n601147M\n601148M\n601149M\n601150M\n601151M\n601152M\n601155M\n601156M\n601157M\n601158M\n601159M\n601160M\n601161M\n601162M\n601164M\n601166M\n601167M\n601169M\n601171M\n601172M\n601173M\n601174M\n601175M\n601176M\n601177M\n601178M\n601179M\n601180M\n601182M\n601185M\n601186M\n601187M\n601190M\n601192M\n601193M\n601194M\n601195M\n601196M\n601197M\n601198M\n601199M\n601200M\n601201M\n601202M\n601203M\n601204M\n601206M\n601207M\n601209M\n601210M\n601211M\n601212M\n601213M\n601214M\n601215M\n601216M\n601217M\n601218M\n601219M\n601221M\n601222M\n601223M\n601224M\n601226M\n601227M\n601230M\n601231M\n601232M\n601233M\n601234M\n601235M\n601236M\n601237M\n601238M\n601241M\n601243M\n601245M\n601246M\n601247M\n601250M\n601251M\n601252M\n601254M\n601255M\n601256M\n601257M\n601258M\n601259M\n601260M\n601265M\n601266M\n601267M\n601268M\n601269M\n601270M\n601271M\n601272M\n601273M\n601274M\n601276M\n601277M\n601280M\n601281M\n601282M\n601284M\n601285M\n601286M\n601287M\n601288M\n601290M\n601291M\n601292M\n601293M\n601294M\n601296M\n601298M\n601299M\n601300M\n601304M\n601307M\n601310M\n601313M\n601320M\n601322M\n601323M\n601325M\n601327M\n601329M\n601330M\n601331M\n601332M\n601333M\n601334M\n601335M\n601348M\n601349M\n601352M\n601356M\n601358M\n601359M\n601362M\n601366M\n601367M\n601375M\n601376M\n601382M\n601386M\n601387M\n601391M\n601392M\n601398M\n601404M\n601417M\n601420M\n601421M\n601424M\n601426M\n601427M\n601428M\n601429M\n601430M\n601431M\n601432M\n601433M\n601434M\n601435M\n601436M\n601437M\n601438M\n601441M\n601442M\n601443M\n601444M\n601447M\n601449M\n601450M\n601455M\n601456M\n601457M\n601461M\n601462M\n601465M\n601467M\n601468M\n601469M\n601479M\n601480M\n601481M\n601482M\n601485M\n601486M\n601487M\n601488M\n601489M\n601491M\n601492M\n601493M\n601495M\n601496M\n601497M\n601498M\n601499M\n601500M\n601501M\n601502M\n601503M\n601504M\n601505M\n601506M\n601507M\n601508M\n601509M\n601510M\n601512M\n601513M\n601514M\n601517M\n601518M\n601519M\n601522M\n601523M\n601527M\n601528M\n601529M\n601530M\n601532M\n601533M\n601534M\n601535M\n601536M\n601538M\n601539M\n601540M\n601542M\n601544M\n601547M\n601548M\n601551M\n601552M\n601553M\n601554M\n601555M\n601556M\n601557M\n601558M\n601560M\n601561M\n601566M\n601567M\n601568M\n601570M\n601573M\n601574M\n601575M\n601583M\n601592M\n601596M\n601606M\n601613M\n601615M\n601616M\n601618M\n601623M\n\nSerial Numbers for PN-0007001:\n601098M\n601099M\n601107M\n601108M\n601110M\n601115M\n601116M\n601117M\n601184M\n601188M\n601189M\n601301M\n601303M\n601306M\n601309M\n601351M\n601572M\n601576M\n601577M\n601584M\n601585M\n601591M", "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 Sipple\n669-231-8200", "reason_for_recall": "An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.", "root_cause_description": "Process control", "action": "On 01/24/2023, the firm communicated an \"MEDICAL DEVICE FIELD ACTION\" Letter via FedEx Standard Overnight to customers informing them that Outset Medical has identified that Tablo Hemodialysis Systems manufactured between May 2021 and February 2022 require recalibration of the conductivity sensor, due to the dialysate conductivity sensor giving potentially false trigger alarms such as Alarm_Dialysate_Conductivity_High or Dialysate Conductivity Error. In addition, in devices where recalibration is needed and isolated only to treatments where the prescribed sodium is less than or equal to 133mEq/L, there may be an unlikely occurrence of delivered dialysate sodium falling outside of listed device specifications. In these remote cases, the need for clinical intervention is not expected.\n\nActions to be taken by Customer/user:\n\" Outset Medical has assessed the risk of this issue and customer's Tablo device can continue to be used until serviced.\n\" Outset request that customers complete the enclosed acknowledgment form and promptly return it to Outset Medical.\n\" Disseminate this information to appropriate personnel within the customer's facility for processing and distribution.\n\nActions to be taken by Outset:\n-Firm will recalibrate the conductivity sensor as part of routine maintenance or at the next service call. An Outset Field Service Engineer will coordinate the completion of the recalibration with your staff to minimize downtime of your Tablo system(s).\n\nAny questions, contact Outset Customer Experience team at 844-MYTABLO or 844-698-2256.", "product_quantity": "374 systems", "distribution_pattern": "U.S. Nationwide distribution including in the states of AK, AL, AR, CA, CO, FL, GA, HI, IA, ID, IL, IN, MI, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, and WI.\n\nO.U.S.: Not provided.", "openfda": { "k_number": [ "K153329", "K994292", "K003957", "K991916", "K102892", "K920186", "K083712", "K863720", "K993520", "K021352", "K030348", "K974127", "K231410", "K022747", "K043344", "K991495", "K121022", "K954928", "K030652", "K001755", "K944767", "K944385", "K250514", "K945066", "K931595", "K080703", "K993877", "K991519", "K791086", "K030059", "K003877", "K014169", "K111740", "K964539", "K251851", "K011005", "K110578", "K945559", "K802474", "K934848", "K842215", "K200670", "K822385", "K071104", "K042018", "K110285", "K161304", "K252181", "K123282", "K061782", "K771763", "K142285", "K013677", "K980182", "K171099", "K983126", "K992786", "K873487", "K143617", "K981085", "K894300", "K093608", "K192398", "K894106", "K800305", "K042089", "K981680", "K133829", "K223656", "K250471", "K924695", "K001282", "K871242", "K022448", "K983512", "K124059", "K051620", "K041163", "K041884", "K131904", "K010592", "K031832", "K223479", "K944493", "K131622", "K090885", "K072158", "K032004", "K182367", "K151637", "K133783", "K042797", "K133149", "K033648", "K161844", "K945136", "K002045", "K841403", "K082400", "K993806", "K974899", "K915258", "K232953", "K954349", "K211035", "K021560", "K000249", "K952215", "K092481", "K001811", "K983239", "K994279", "K060942", "K213507", "K811678", "K112331", "K993200" ], "device_name": "Subsystem, Water Purification", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5665", "device_class": "2", "registration_number": [ "3005578748", "3035708507", "3010120326", "1720309", "3004188066", "3010866895", "1530185", "3019131", "9611824", "3006426779", "3010178296", "8010182", "3010863450", "3005695808", "9611823", "8030665", "3006755813", "3012119281", "3010120135", "3004057358", "3002879653", "3013764800", "3043543260", "3010041430", "3014279513", "1833407", "9615942", "3038195011", "3010867648", "9610270", "3032828299", "3043014136", "3009959868", "3007007791", "9611369", "3016096143", "3017974963", "3010120148", "3003768032", "1055109", "3013507157", "3010032903", "3010355846", "3015349756", "3014144799", "3015335038", "3003337893", "3006029151", "3038138522", "1833387", "1651723", "3017552925", "3004111573", "3010850471", "3002807295", "1225714", "1651434", "3005162618", "1833920", "3003550196" ], "fei_number": [ "3005578748", "3035708507", "3010120326", "1720309", "3004188066", "3010866895", "3001451489", "3006475063", "3003550196", "3006426779", "1000518597", "3010863450", "3005695808", "1000515504", "3003110073", "3006755813", "3012119281", "3010120135", "3012394756", "3004057358", "3002879653", "3003043063", "1000115656", "3003200197", "3013764800", "3043543260", "3010041430", "3014279513", "3010867648", "3032828299", "3043014136", "3002807744", "3009959868", "3007007791", "1527681", "3016096143", "3017974963", "3010120148", "3013507157", "3010032903", "3010355846", "3015349756", "3014144799", "3015335038", "3003337893", "3002806960", "1000191953", "3006029151", "3038138522", "1833387", "3002807005", "3013942511", "3002807035", "3017552925", "3004111573", "3010850471", "3002807295", "1000112932", "3038195011", "3002807204" ] } } ] }