BEUDAMED
    FDA Recall Terminated

    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

    Recall: Z-2179-2017 · Initiated February 6, 2017

    Recall

    Recall Number
    Z-2179-2017
    Event Number
    76517
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    IXR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2017
    Posted
    May 22, 2017
    Terminated
    March 2, 2018
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

    Reason

    Reported incidents of a patient step detaching from the table. A fall from a patient step detaching while in use could result in an injury to a patient or operator.

    Action

    Consignees were sent on 2/6/2017 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10908 dated February 3rd, 2017. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator & Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact consignee to arrange for the correction.. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

    Distribution

    US: Nationwide including DC and Puerto Rico. OUS: Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Egypt, France, Germany, Greece, Honduras, Hungary, Indonesia, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Libya, Malaysia, Malta, Mexico, Panama, Portugal, Russia, Saudi Arabia, Saudi Arabia, Slovakia, Spain, Thailand, United Arab Emirates, United Kingdom, Vietnam.

    Quantity

    2,380 (2,215 US; 165 OUS)