BEUDAMED
    FDA Recall Terminated

    Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.

    Recall: Z-2436-2008 · Initiated July 25, 2008

    Recall

    Recall Number
    Z-2436-2008
    Event Number
    49105
    Firm
    GE Healthcare
    FEI Number
    2126677
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 25, 2008
    Posted
    September 20, 2008
    Terminated
    December 10, 2011
    Address
    3000 N Grandview Blvd, Waukesha, WI, 53188-1615

    Description

    Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology.

    Reason

    The charger and / or battery of the PDB may fail earlier than expected with no advance warning and thus cause the system to shut down.

    Action

    Consignees (Hospital Administrators; Hospital Risk Management Department; Mangers of Radiology/Cardiology; Radiologists/Cardiologists) were sent a "GE Urgent Medical Device Correction" letter dated July 2008. The letter described the affected products; the problem; and the user instructions, which state that the hospital should establish emergency workflow procedures to ensure patient safety should a component stop operating during a patient examination. Facilities should verify if their system has been impacted by checking if the catalog numbers listed are referenced on the PDB panel located in the equipment room. The letter also states the GE Healthcare Resolution Plan, includes correcting the condition, and contact Information.

    Distribution

    Nationwide Distribution --- including states of CA, FL, NY, AK, AL, AR, AZ, PA, FL ,CO, SC, CT, IA, DC, DE, GA, HI, IL , IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NJ, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and GUAM.

    Quantity

    229