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Tablo(R) Hemodialysis System recallZ-0019-2025 · Outset Medical, Inc. · initiated Aug 1, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Outset Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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]).

Recall details

Recall number
Z-0019-2025
Status
Open, Classified
Initiated by the company
Aug 1, 2024
Posted by the FDA
Oct 3, 2024
Recalling firm
Outset Medical, Inc.
Quantity
2,422
Product code
KDI
FDA submissions
K233335
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 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.

Code information (models, lots, serial numbers)

Show the full code information (19k characters)

UDI-DI: 00850001011112, 00850001011204. 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Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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