BEUDAMED
    FDA Recall Terminated

    Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.

    Recall: Z-2465-2008 · Initiated September 3, 2008

    Recall

    Recall Number
    Z-2465-2008
    Event Number
    49500
    Firm
    Ferno-Washington Inc
    FEI Number
    1523574
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 3, 2008
    Posted
    September 30, 2008
    Terminated
    September 27, 2012
    Address
    70 Weil Way, Wilmington, OH, 45177

    Description

    Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes.

    Reason

    The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation.

    Action

    On 9-03-2008 the firm sent via certified mail Urgent Voluntary Correction letters to their customers instructing them to immediately inspect the stretcher according to the 35X PROFlexx Leg Inspections instruction sheet. Customers are to also telephone the firm upon completion of the inspection to arrange for a replacement kit. Contact Ferno Technical Support at 1-866-987-3776 for assistance.

    Distribution

    Worldwide Distribution --- USA including states of AK, AL, AR, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NM, NY,OH, OK, PA, SC, TN, TX, VA, WI, and WV, and countries of Austria, China, Egypt, Germany, Hong Kong, Japan, Lebanon, Mexico, Poland, United Kingdom, and South Africa.

    Quantity

    2,100