BEUDAMED
    FDA Recall Terminated

    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.

    Recall: Z-1864-2021 · Initiated April 19, 2021

    Recall

    Recall Number
    Z-1864-2021
    Event Number
    87863
    Firm
    GE Healthcare, LLC
    FEI Number
    2126677
    Product Code
    OWB
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    April 19, 2021
    Posted
    June 15, 2021
    Terminated
    August 31, 2023
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.

    Reason

    The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor display screen.

    Action

    The recalling firm issued letters dated 4/19/2021 via traceable mail on 4/20/21 and issued an additional letter dated 4/28/2021 to correct an omission of serial numbers (only sent to the affected consignees).

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, CO, FL, GA, KY, LA, MA, MO, MS, NC, NJ, NV, NY, PA, SC, TN, TX, VA, WA, and WI. Government distribution was made and potentially military distribution was made. The countries of Algeria, Argentina, Canada, China, Dominican Republic, Finland, France, Germany, Hungary, India, Indonesia, Iran, Iraq, Italy, Japan, Korea, Kuwait, Mexico, Moldova, Morocco, Poland, Russia, Spain, Sudan, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uzbekistan.

    Quantity

    139 devices