BEUDAMED
    FDA Recall Open, Classified

    Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

    Recall: Z-0813-2022 · Initiated January 20, 2022

    Recall

    Recall Number
    Z-0813-2022
    Event Number
    89616
    Firm
    Outset Medical, Inc.
    FEI Number
    3010355846
    Product Code
    KDI
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 20, 2022
    Address
    3052 Orchard Dr, San Jose, CA, 95134-2011

    Description

    Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000

    Reason

    Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

    Action

    On 01/20/2022, the firm send a "MEDICAL DEVICE FIELD ACTION" Letter to customers informing them that Outset Medical is proactively replacing a component on the Talbo Hemodialysis consoles due to the possibility of heat-related damage that may occur to the Tablo device. Outset Medical has identified that Tablo Hemodialysis Systems manufactured between July 6, 2018 and November 24, 2021 require the component replacement. Outset is indicating that the replacement will be completed within the next twelve months during the next routine maintenance or at the next service call. Outset Field Service Engineers will coordinate completion of the replacement. Customers are instructed to complete the acknowledgement form and promptly return to Outset Medical For questions, contact Outset Customer Experience Team at 844-698-2256.

    Distribution

    U.S. Nationwide distribution in the states of AL, AK, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NM, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY.

    Quantity

    1,123 systems (PN-0003000) and 1,487 (PN-0006000)