BEUDAMED
    FDA Enforcement Class II Terminated

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    Recall: Z-1247-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1247-2015
    Event ID
    68235
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arjo Hospital Equipment AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    September 1, 2014
    Classification Date
    March 6, 2015
    Termination Date
    January 4, 2016
    Address
    HANS MICHELSENSGATAN 10, N/A, Malm¿, N/A, N/A, Sweden

    Description

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    Reason

    The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

    Code Info

    All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.

    Distribution

    Nationwide Distribution.

    Quantity

    1,034 units