BEUDAMED
    FDA Recall 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 · Initiated September 1, 2014

    Recall

    Recall Number
    Z-1247-2015
    Event Number
    68235
    Firm
    Arjo Hospital Equipment AB HANS MICHELSENSGATAN
    FEI Number
    3002806395
    Product Code
    IKY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 1, 2014
    Posted
    March 6, 2015
    Terminated
    January 4, 2016
    Address
    10 Malm¿ 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.

    Action

    On 9/1/14 the recalling firm sent out a letter to their customers notifying them of an updated IFU for the recalled device. The letter also requested the customers to verify the quantity of the product they currently have on hand.

    Distribution

    Nationwide Distribution.

    Quantity

    1,034 units