BEUDAMED
    FDA Recall Terminated

    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

    Recall: Z-2605-2016 · Initiated July 11, 2016

    Recall

    Recall Number
    Z-2605-2016
    Event Number
    74737
    Firm
    American National Mfg Inc
    FEI Number
    3000204953
    Product Code
    FNM
    Status
    Terminated
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    July 11, 2016
    Terminated
    January 17, 2017
    Address
    252 Mariah Cir, Corona, CA, 92879-1751

    Description

    Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000. Use with alternating pressure air flotation mattress.

    Reason

    The Panacea Air Pro Mattress Control Unit is being recalled due to a firmware problem, which may result in the device not having the firmness range required.

    Action

    An Urgent Medical Device Recall letter, dated 7/11/16, was sent to customers to inform them of a recall involving the Panacea Air Pro Mattress Control Unit also labeled as Platinum 5000, US Model Number 5000, Serial numbers 9500051 through 9500300. The letter informs the customers that the recall has been identified due to firmware problem. The letter informs the customers of the problem identified and the actions to be taken. Customers were asked to immediately examine their inventory and quarantine the affected device. A shipping label would be provided for return and update of the affected devices. All customers that the device was further distributed to would need to be notified of the recall.

    Distribution

    Distributed to the US -- WI, OH, IL, TX, AZ, MD, IA, PA, CO, WA, ID, MN, LA, WY, and MS.

    Quantity

    31 units