BEUDAMED
    FDA Recall Terminated

    GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

    Recall: Z-0966-2015 · Initiated December 10, 2014

    Recall

    Recall Number
    Z-0966-2015
    Event Number
    70073
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 10, 2014
    Posted
    January 14, 2015
    Terminated
    June 1, 2015
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare, Discovery IGS 730 & Discovery IGS 740. Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures. Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.

    Reason

    Potential unintentional system motion or rotation due to a positioning user interface issue with Discovery IGS 730 and 740 products.

    Action

    Consignees were sent a 12/10/2014 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 12223 dated December 10, 2014. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology / Cardiology and Radiologists / Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information ( US call 800-437-1171, other countries contact your local GE Healthcare Service Representative).

    Distribution

    Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.

    Quantity

    24 ( 7 US, 17 OUS)