BEUDAMED
    FDA Recall Terminated

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    Recall: Z-1631-2014 · Initiated March 18, 2014

    Recall

    Recall Number
    Z-1631-2014
    Event Number
    67924
    Firm
    SCM True Air Technologies LLC
    FEI Number
    3001452084
    Product Code
    OSI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 18, 2014
    Posted
    May 19, 2014
    Terminated
    June 11, 2018
    Address
    7955 National Tpke, Unit 100, Louisville, KY, 40214-4903

    Description

    ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

    Reason

    The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

    Action

    SCM True Air Technologies LLC sent an Urgent Medical Device Recall letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from use and return to True Air Technologies immediately. The units should be decontaminated and bagged with a certification of disinfection before return to True Air Technologies. True Air will provide replacement units to replace the returned units. Customers were instructed to refer to the Medical Device Recall Return Response Form attached for acknowledgement of receipt and contact information for this voluntary recall. Customers with questions should call 800-682-7163.

    Distribution

    Nationwide Distribution including GA, KY, and MI.

    Quantity

    48 beds