BEUDAMED
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    Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility.

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code FIP·January 24, 2023

    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.

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code KDI·August 1, 2024

    Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code KDI·March 6, 2024

    TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System.

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code KDI·April 30, 2024

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

    FDA Recall
    Open, Classified ·Outset Medical, Inc.·Product code KDI·January 20, 2022

    Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

    FDA Recall
    Open, Classified ·Breas Medical, Inc.·Product code NOU·July 25, 2024