Events

Recall of Device Recall GE Healthcare Optima CT580/Discovery CT590RT scanners

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
    67592
  • Event Risk Class
    Class 2
  • Event Number
    Z-1245-2014
  • Event Initiated Date
    2014-02-14
  • Event Date Posted
    2014-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125799
  • 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, tomography, computed - Product Code JAK
  • Reason
    Ge healthcare has recently become aware of a potential safety issue due to a software issue associated with the head scan protocols used on your optima ct580 or discovery ct590rt scanner. a potential hazardous situation may occur during a ct head scan causing a novel and rare artifact that may hide pathology. when using the head and large head sfov, which applies the iterative bone option (ibo).
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 14, 2014 to its Consignees. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees were instructed to ensure that all potential users in your facility are made aware of this safety notification and recommended actions. A GE Healthcare Service representative will perform the required software update on each affected system. This activity will be performed at no cost to consignees. Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and in other countries, please contact your local GE Healthcare Service Representative.

Device

Device Recall GE Healthcare Optima CT580/Discovery CT590RT scanners
  • Model / Serial
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: CO, IN, MA, NJ, NC, OH, PA, TX, and VA; and countries of: Algeria,France, Germany, Poland, Russia, and Taiwan.
  • Product Description
    GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. || The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.
  • 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