FDA Device Recall Z-0019-2025: Outset Medical, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0019-2025.

Recall Res Number

Z-0019-2025

Recalling Firm / Manufacturer

Outset Medical, Inc.

FEI Number

3010355846

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-08-01

Date Posted

2024-10-03

Date Terminated

N/A

Product Code

KDI

Event Number

95294

Product Quantity

2,422

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.

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.

Action Details 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 FieldActionAdvisory@OutsetMedical.com If you have any questions regarding this notification contact the firm's Technical Support team (844-698-2256 or support@outsetmedical.com).

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. OUS: UAE

Code Information / Serial Numbers 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

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0019-2025

Recall Parameters & Description

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