BEUDAMED
    FDA Enforcement Class II Terminated

    AC Powered hospital adjustable bed.

    Recall: Z-2205-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2205-2020
    Event ID
    85592
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Umano Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2020
    Initiation Date
    May 4, 2020
    Classification Date
    June 2, 2020
    Termination Date
    December 30, 2020
    Address
    230 Nilus-Leclerc Blvd, N/A, L'Islet, N/A, N/A, Canada

    Description

    AC Powered hospital adjustable bed.

    Reason

    Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

    Code Info

    Model FL36 Numbers OL360011P or OL360017P

    Distribution

    Domestic distribution: AR, CA, FL, GA, UT, MS, NY, PA International distribution: Australia, Brasil, Canada and United Kingdom.

    Quantity

    3259 beds