BEUDAMED
    FDA Enforcement Class II Terminated

    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.

    Recall: Z-0208-2013 · Reported November 14, 2012

    Enforcement

    Recall Number
    Z-0208-2013
    Event ID
    52796
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sechrist Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 14, 2012
    Initiation Date
    August 28, 2008
    Classification Date
    November 6, 2012
    Termination Date
    November 6, 2012
    Address
    4225 E La Palma Ave, N/A, Anaheim, CA, 92807, United States

    Description

    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/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.

    Code Info

    Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075.

    Distribution

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

    Quantity

    73 units