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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 01, 2024
Date PostedOctober 03, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0019-2025
Recall Event ID 95294
510(K)NumberK233335 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
ProductTablo 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 Information UDI-DI: 00850001011112, 00850001011204. Serial Numbers: 400405, 602382M, 602384M, 602387M, 602400M, 602402M, 601124M, 601156M, 601102M, 601265M, 400109, 602248M, 602659M, 602670M, 602767M, 602769M, 602771M, 601356M, 602421M, 602403M, 400394, 601728M, 601730M, 601731M, 601733M, 601735M, 601736M, 601738M, 601771M, 601772M, 601774M, 600599M, 600614M, 600615M, 600620M, 600631M, 600641M, 600646M, 600648M, 600654M, 600659M, 601337M, 601357M, 601360M, 601361M, 601364M, 601368M, 601384M, 601395M, 601396M, 601422M, 601727M, 602748M, 600189, 601515M, 601513M, 601514M, 601517M, 601518M, 601838M, 601864M, 601870M, 601915M, 601924M, 601823M, 601854M, 601861M, 601887M, 601901M, 601908M, 601923M, 601903M, 601936M, 601945M, 601974M, 601799M, 600484M, 601876M, 601886M, 601938M, 601941M, 600488M, 601129M, 601146M, 601270M, 601298M, 601797M, 601805M, 601812M, 601814M, 601821M, 601855M, 601890M, 601897M, 601932M, 601934M, 600563M, 600569M, 600572M, 600574M, 601952M, 601954M, 601878M, 601899M, 601935M, 601942M, 601943M, 601947M, 601800M, 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Recalling Firm/
Manufacturer
Outset Medical, Inc.
3052 Orchard Dr
San Jose CA 95134-2011
For Additional Information Contact
669-231-8200
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
ActionOn 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).
Quantity in Commerce2,422
DistributionUS: 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
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KDI
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