BEUDAMED
    FDA Enforcement Class II Ongoing

    Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

    Recall: Z-1472-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1472-2026
    Event ID
    98332
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Agiliti Health - Ellis
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 4, 2026
    Initiation Date
    January 21, 2026
    Classification Date
    February 26, 2026
    Address
    204 W 2nd St, N/A, Ellis, KS, 67637-2026, United States

    Description

    Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure

    Reason

    Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.

    Code Info

    UDI-DI 0084569904914; All serial numbers with a manufacturing date prior to 12/04/2025

    Distribution

    US Nationwide distribution.

    Quantity

    4286