Outset Medical, Inc.: 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.

Recall number

Z-0019-2025

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.

Status

Open, Classified

Initiated

2024-08-01

Posted

2024-10-03

Terminated

not on file

Reason

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

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 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

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

Lot, serial or model codes

UDI-DI: 00850001011112, 00850001011204. 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510(k) numbers

K233335

PMA numbers

not on file

Product code

KDI

Firm FEI

3010355846

Firm city

San Jose

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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