Events

Recall of Device Recall GE Healthcare Innova

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
    59944
  • Event Risk Class
    Class 2
  • Event Number
    Z-1124-2012
  • Event Initiated Date
    2011-05-04
  • Event Date Posted
    2012-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104048
  • 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
    System, x-ray, angiographic - Product Code IZI
  • Reason
    It was discovered that when the diamentor m4-kdk is installed on an innova system the dose display is disabled on the certified innova monitor and enabled on the diamentor m4-kdk which is not certified as required by fda regulation (subpart j).
  • Action
    GE Healthcare will alert affected Innova users with a Diamentor M4-KDK unit of this issue and the workaround to mitigate this issue. GE Healthcare will bring affected Innova units in the field into compliance by enabling the Innova certified display and providing affected customers with an Operators Manual Addendum and Service Manual Addendum which will address this topic. GE Healthcare will correct all affected systems by updating the system's Operator and Service Correction manuals and enabling the innova dose display on the Live and Reference monitors and the DLconsole. The Diamentor M4-KDK can still be used to display additional informative dose values. GE Healthcare will, without charge, remedy the defect or bring the product into compliance; the details of which will be included in a subsequent communication to you or through a GE field engineer site visit. GE Healthcare updated the Innova User Instructions, as part of the recall, to indicate to meet regulatory requirements based on the international safety standards IEC 60601-2-43:2000 and/or 21 CFR 1020.30 (k), use as reference the exposure dose displayed on the DL console, live or reference monitor. If you have any further questions or concerns please call 800-437-1171.

Device

Device Recall GE Healthcare Innova
  • Model / Serial
    Innova 2100, 3100, 4100, 2121, and 3131
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    GE Healthcare Innova X-ray Imaging Systems. || The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. This device is not intended for mammography applications.
  • 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