BEUDAMED
    FDA Recall Terminated

    Sara Plus Active Floor Lift

    Recall: Z-1098-2022 · Initiated April 5, 2022

    Recall

    Recall Number
    Z-1098-2022
    Event Number
    89960
    Firm
    ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ul. Ks. Piotra Wawrzyniaka 2 Komorniki Poland
    FEI Number
    3007420694
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 5, 2022
    Posted
    May 21, 2022
    Terminated
    September 5, 2024

    Description

    Sara Plus Active Floor Lift

    Reason

    The device may emit smoke or ignite.

    Action

    A customer letter was sent to consignees on 04/08/2022. The customer are asked to acknowledge the notification, complete and sign off an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the notification). The notification contains the list of precautionary measures to be taken by caregivers in order to minimize the likelihood of the failure until their lifts are corrected by Arjo. The device correction (including PCB upgrade and cover replacement) is to be performed by Arjo personnel, free of charge.

    Distribution

    US Nationwide and Worldwide distribution

    Quantity

    4449 devices