Z-0019-2025Class II
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis...
Outset Medical, Inc. / initiated 2024-08-01 / Open, Classified / root cause: manufacturing process
Outset Medical, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0019-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Outset Medical, Inc.
- Product
- 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.
- Product code
- KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
- 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 tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- On 8/1/24, field action notices were sent to customers who were asked to do the following: Component 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. Disseminate 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. Identify and notify your home patients with affected devices of this component replacement. Accounts that have completed the firm's biomedical engineering training program and service their systems will receive additional information. Complete and return the response form via email to [email protected] If you have any questions regarding this notification contact the firm's Technical Support team (844-698-2256 or [email protected]).
- Quantity in commerce
- 2,422
- Distribution
- 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. OUS: UAE
- Product codes and lots
- UDI-DI: 00850001011112, 00850001011204. 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601536M, 601256M, 601257M, 601258M, 601278M, 601285M, 602315M, 602318M, 602156M, 602164M, 400916, 602250M, 601948M, 601951M, 600354M, 600355M, 600368M, 600373M, 600387M, 600388M, 602553M, 602556M, 602557M, 602741M, 602742M, 602714M, 602716M, 602717M, 602730M, 602731M, 602732M, 601011M, 601016M, 600624M, 600855M, 601386M, 602805M, 602824M, 602399M, 602405M, 602407M, 602413M, 602416M, 601544M, 601550M, 601551M, 601552M, 601554M, 601561M, 601562M, 601022M, 401177, 600764M, 600769M, 601567M, 601534M, 601539M, 601553M, 601557M, 601293M, 601294M, 601296M, 601203M, 601205M, 601243M, 600225, 600228, 601168M, 600336M, 400981, 600096, 601739M, 601068M, 601077M, 601200M, 601208M, 601215M, 601216M, 601572M, 601576M, 601577M, 601582M, 601585M, 601586M, 601591M, 602542M, 602543M, 602544M, 602547M, 602548M, 602549M, 600155M, 600537M, 600582M, 600587M, 600589M, 600590M, 601437M, 600819M, 601667M, 600029M, 600251M, 600259M, 600750M, 600761M, 600772M, 600775M, 600827M, 600672M, 600674M, 600675M, 600678M, 600681M, 600682M, 600683M, 601153M, 601333M, 601334M, 601335M, 601336M, 602037M, 602111M, 602112M, 602113M, 602114M, 602122M, 602125M, 602130M, 602132M, 602135M, 601191M, 601241M, 601255M, 601268M, 401141, 600376M, 600391M, 600670M, 600845M, 600846M, 600758M, 601490M, 600133M, 600153M, 600630M, 600151M, 600627M, 601758M, 601769M, 602078M, 600706M, 600708M, 600709M, 600783M, 601575M, 601583M, 601888M, 601894M, 601904M, 601911M, 600115M, 600118M, 600878M, 600883M, 601781M, 601785M, 601807M, 601839M, 602480M, 602487M, 602497M, 602501M, 602505M, 602491M, 602495M, 602502M, 602506M, 600082M, 600900M, 600608M, 602280M, 602282M, 602285M, 602286M, 600244, 601794M, 601795M, 602341M, 602347M, 602350M, 602453M, 602457M, 600842M, 600844M, 602550M, 602551M, 602552M, 602555M, 602568M, 602645M, 602658M, 602669M, 602674M, 602676M, 602678M, 602653M, 602666M, 602554M, 602565M, 602205M, 602203M, 602196M, 602200M, 602204M, 600685M, 600692M, 600711M, 600720M, 600722M, 601161M, 601623M, 601287M, 601288M, 601289M, 600748M, 600751M, 601375M, 601167M, 601304M, 602488M, 602489M, 601984M, 601985M, 601986M, 602588M, 602593M, 602517M, 602589M, 602591M, 601634M, 602208M, 601275M, 601365M, 601382M, 601519M, 601635M, 602079M, 601387M, 601147M, 601541M, 602587M, 602048M, 602085M, 600984M, 602246M, 601046M, 602042M, 602044M, 602090M, 602158M, 602621M, 602598M, 602258M, 600481M, 601472M, 602536M, 601327M, 601483M, 602223M, 602484M, 601343M, 601618M, 601682M, 602662M, 601127M, 601179M, 601627M, 602235M, 602339M, 600324, 600397M, 600464M, 600544M, 600972M, 600973M, 600978M, 601029M, 601154M, 601638M, 601803M, 602061M, 602066M, 602074M, 602152M, 602176M, 602460M, 600463M, 601002M, 601568M, 601725M, 602091M, 602054M, 601087M, 602791M, 601431M, 601630M, 602143M, 602178M, 600607M, 601548M, 601556M, 602151M, 602154M, 602179M, 602233M, 602240M, 602126M, 601421M, 602409M, 602193M, 601143M, 601481M, 600346M, 600995M, 601144M, 601158M, 601160M, 602039M, 602046M, 602047M, 602051M, 601711M, 601222M, 601254M, 602180M, 601661M, 602498M, 602041M, 602055M, 601135M, 602034M, 602057M, 602440M, 600814M, 600862M, 602109M, 602595M, 600338M, 602473M, 601469M, 602269M, 601277M, 602174M, 600348M, 600365M, 600428M, 600455M, 600993M, 601212M, 602059M, 602086M, 602140M, 602149M, 602469M, 602478M, 602482M, 602077M, 601656M, 602100M, 601675M, 602522M, 601654M, 602110M, 602395M, 602455M, 602443M, 601559M, 602770M, 601467M, 600364M, 602600M, 602137M, 602367M, 600396M, 600426M, 601238M, 601264M, 602144M, 602153M, 602249M, 602259M, 601607M, 602585M, 602458M, 601751M, 602095M, 602206M, 600514M, 600494M, 600500M, 600556M, 602459M, 600271M, 600516M, 600613M, 601140M, 601142M, 601292M, 601322M, 602094M, 602096M, 602104M, 600269M, 600270M, 601136M, 602062M, 601663M, 600482M, 602064M, 602171M, 600992M, 602076M, 602463M, 601757M, 600480M, 601560M, 601610M, 602145M, 601468M, 601629M, 600457M, 600996M, 601173M, 601180M, 601597M, 601631M, 601632M, 601669M, 602260M, 602372M, 601603M, 600474M, 601155M, 600486M, 601636M, 602049M, 602052M, 602058M, 602084M, 602239M, 602045M, 602256M, 601666M, 602227M, 602093M, 602155M, 602254M, 601443M, 601473M, 600551M, 600632M, 600668M, 600439M, 601362M, 602036M, 602043M, 602050M, 602119M, 600491M, 601150M, 602081M, 601341M, 601633M, 601415M, 602138M, 600622M, 602289M, 602780M, 601813M, 601543M, 602607M, 601366M, 601376M, 602586M, 602583M, 600461M, 602273M, 600447M, 600467M, 602628M, 602483M, 602545M, 602127M, 602107M, 601342M, 602599M, 601344M, 602177M, 602461M, 600859M, 400424, 400425, 401243, 400995, 602265M, 602268M, 602270M, 601521M, 601522M, 401262, 602162M, 602181M, 602266M, 602378M, 602380M, 602215M, 602228M, 602263M, 602116M, 602117M, 600865M, 600873M, 600889M, 600716M, 600717M, 600719M, 600625M, 600628M, 602601M, 601471M, 601474M, 601475M, 601478M, 601391M, 601392M, 602794M, 601428M, 602655M, 600501M, 600982M, 601352M, 602302M, 602366M, 600583M, 600983M, 602313M, 602375M, 601411M, 601420M, 602752M, 602661M, 601410M, 602646M, 602467M, 602602M, 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0019-2025 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.