BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

    Recall: Z-1989-2013 · Initiated May 2, 2013

    Recall

    Recall Number
    Z-1989-2013
    Event Number
    65862
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 2, 2013
    Posted
    August 20, 2013
    Terminated
    November 26, 2013
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

    Reason

    GE Healthcare has recently become aware of a potential safety issue involving the overhead Video Monitor Suspension involving Precision 500D Systems. There is a potential for the locking nut to loosen out of the Video Monitor Suspension yoke which could result in impact. This will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and

    Action

    GE Healthcare "Urgent Medical Device Correction" letter dated May 1, 2013 to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter informed customers that GE Healthcare will correct all affected systems at no cost. A GE Healthcare service representative will contact you to arrange for this correction. For questions or concerns regarding this notification call: US 800-437-1171, Japan: 0120-055-919.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.

    Quantity

    445 (421 US, 24 OUS)