Events

Recall of Device Recall Innova 2000 Digital Flouroscopic Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    55921
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2010
  • Event Initiated Date
    2010-06-10
  • Event Date Posted
    2010-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92241
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Solid state x-ray imager (flat panel/digital imager) - Product Code MQB
  • Reason
    A hardware component (potentiometer and encoder)mismatch in innova 2000 digital fluoroscopic imaging systems may cause a source to image distance (sid) failure, which will cause the imager to fail to detect the distance between the imager and the patient. this will result in loss of the x-ray image if the recovery process is not performed. the error message to use the emergency back-out button for.
  • Action
    GE Healthcare sent a GE "Urgent Medical Device Correction" dated June 9, 2010letter to consignees. The letter was addressed to Hospital Administrators / Risk Mangers; Mangers of Radiology/Cardiology and Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details; Safety Instruction; Product Correction and Contact Information. The letter detailed the method for identifying SID failure and the use of the emergency back-out buttoms to recover the X-ray image. A GE service representative will affix a label to the device on-site to remind operators how to recover from loss of X-ray from SID failure. Consignees may contact GE at 800 437-1171, option 4.

Device

Device Recall Innova 2000 Digital Flouroscopic Imaging System
  • Model / Serial
    Serial 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: States of AL, AZ, AR, CA, CO, CT,DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV,NH, NJ, NM, NH,NC, ND, OH, OK OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and countries of VENEZUELA, UNITED KINGDOM, TURKEY, TUNISIA, THAILAND, TAIWAN, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN SPAIN, SOUTH AFRICA, SAUDI ARABIA, RUSSIAN FEDERATION, REPUBLIC OF KOREA, POLAND, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, LITHUANIA, LEBANON, JORDAN, JAPAN, ITALY, ISRAEL, ISLAMIC REPUBLIC OF IRAN, IRELAND, INDONESIA, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, EGYPT , ECUADOR, COLOMBIA, CHINA, CANADA, BULGARIA, BRAZIL, BELGIUM, BELARUS, AUSTRALIA, and ALGERIA.
  • Product Description
    Innova 2000, manufactured by GE Medical Systems, SCS
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA