BEUDAMED
    FDA Recall Terminated

    Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502, Sechrist Industries, Inc., Anaheim, CA

    Recall: Z-0733-2008 · Initiated October 31, 2007

    Recall

    Recall Number
    Z-0733-2008
    Event Number
    45906
    Firm
    Sechrist Industries Inc
    FEI Number
    2020676
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 31, 2007
    Posted
    January 18, 2008
    Terminated
    April 19, 2012
    Address
    4225 E La Palma Ave, Anaheim, CA, 92807-1815

    Description

    Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model, P/N : 21502, Sechrist Industries, Inc., Anaheim, CA

    Reason

    Brake Problems: The stretcher brake cams may crack while attempting to lock the stretcher brake (Sechrist is supplied the stretchers by the manufacturer Stryker Medical)

    Action

    Urgent Medical Device Correction letters were sent to customers beginning on November 9, 2007, via FedEx & DHL overnight. Customers were notified this action was being taken to providing notification to their customers as a continued implementation of the Stryker Medical field correction. The Notification letter instructed their customers to: 1. Locate the gurneys with the serial numbers listed in this advisory. 2. If any of the affected gurneys cannot be located, determine if they have been sold, transferred, or donated to another facility and notify us regarding their new location. 3. Verify the brakes are working properly. The brake function may be checked by engaging the brake pedal and pushing on each end of the gurney to make sure that casters are locked securely. 4. Remove the gurneys with non-functioning brakes from service until brake cams have been replaced and brakes are fully functional. 5. Contract Sechrist for the replacement parts package. 6. Complete the retrofit of the Gurney. 7. Verify correct function of the brake assembly following retrofit. 8. Complete and send the Correction Verification Form contained in the package to Sechrist.

    Distribution

    Worldwide-USA, Brazil, Bulgaria, Canada, Dubai, U.A.E., Estonia, India, Indonesia, Japan, Malaysia, Saudi Arabia, Sweden, Taiwan, Thailand, and Vietnam.

    Quantity

    559 Units Total (483 in US) for all models