Recall of Device Recall Innova 2000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, 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
    52703
  • Event Risk Class
    Class 2
  • Event Number
    Z-2240-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Ge healthcare has recently became aware of a potential power supply failure with the innova¿ 2000, 3100 and 4100 systems that may impact patient safety. a potential power supply failure inside the ge equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. should this occur, the system cannot be restarted.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated June 25, 2009. The letter was addressed to Hospital Administrators/Risk Managers, Managers of Radiology/Cardiology or Radiologists/Cardiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will correct all affected systems by replacing the power supply located in the GE equipment cabinet. A GE Healthcare service representative will contact you to arrange for this correction. Direct questions about the recall to the firm's Call Center by calling: 1-800-437 -1171, option 4 (United States) or 0120 - 055 - 919 (Japan). For other countries, please contact your local GE Healthcare field service Representative if you have any questions or concerns regarding the notification.

Device

  • Model / Serial
    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422771BU6 00000421701BU4 00000422469BU7 00000394209BU1 00000392580BU7 00000416864BU7 00000418000BU6 00000407955BU4 00000406792BU2 00000427204BU3 000000393456U9 00000406785BU6 00000394044BU2 00000408600BU5 00000421608BU1 00000411914BU5 00000423019BU9 00000398007BU5 00000389235BU3 00000397408BU6 00000387191BU0 and 00000403958BU2.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (states of AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA., MI, MN, MO, NE, NV, NH, NJ, NY, NC, OH, OK , OR, PA, PR, RI, SC, TN, TX, UT VA, WA, WI and WV), TUNISIA, THAILAND , TAIWAN, SYRIAN ARAB REPUBLIC, SWEDEN SPAIN, SOUTH AFRICA SAUDI ARABIA, RUSSIAN FEDERATION , POLAND, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MEXICO, MARTINIQUE, MACAU, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, ISRAEL, IRAN, INDONESIA, INDIA, GREECE, GERMANY, FRANCE , CHINA, CANADA, BULGARIA, BRAZIL BELGIUM, BELARUS and AUSTRALIA.
  • Product Description
    GE, Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. || Innova¿ 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities.
  • Manufacturer

Manufacturer

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