BEUDAMED
    FDA Recall Terminated

    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures

    Recall: Z-0209-2013 · Initiated August 28, 2008

    Recall

    Recall Number
    Z-0209-2013
    Event Number
    52796
    Firm
    Sechrist Industries Inc
    FEI Number
    2020676
    Product Code
    CBF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 28, 2008
    Posted
    November 6, 2012
    Terminated
    November 6, 2012
    Address
    4225 E La Palma Ave, Anaheim, CA, 92807

    Description

    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures

    Reason

    Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber.

    Action

    Sechrist Industries contacted consignees by phone to notify them of a software upgarde and to schedule appointments to perform the required field upgrades. An approximate summary of the phone notification is provided below. "I am contacting you to notify you of a field upgrade we are performing on our hyperbaric chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of your chamber. The upgrade includes the installation of a new motherboard with revised software, a reset switch, and the exchange of other control panel components. The process will take approximately 2.5 hours and will be performed at no charge to you." For questions regarding this recall call 714-579-8400.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Bulgaria, and Canada

    Quantity

    65 units total (61 units in the US)