Events

Recall of Device Recall Innova 3100

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-2241-2009
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83679
  • 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

Device Recall Innova 3100
  • Model / Serial
    00000423793BU9 00000424103BU0 00000427535BU0 00000429845BU1 00000430039BU8 and 00000410867BU6.
  • Product Classification
    Radiology Devices
  • 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
    Innova¿ 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). || The Innova¿ systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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