Events

Recall of Device Recall HiSpeed FX/I

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
    56400
  • Event Risk Class
    Class 2
  • Event Number
    Z-0778-2011
  • Event Initiated Date
    2010-02-01
  • Event Date Posted
    2011-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96336
  • 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
    Computed Tomography X-Ray System - Product Code JAK
  • Reason
    A defect with the hardware and software displaying the incorrect dose data.
  • Action
    Important Electronic Product Radiation Warning letter was sent to customers identifying the affected product, explaining the defect and related hazards, giving instructions, and the product correction. Customers are to decrease the CTDI value by a factor of 30% when using 5, 7, 10 mm slice thickness, and by a factor of 20% when using 3 mm slice thickness for more accurate estimate of the CTDI. GE Healthcare will remedy the defect free of charge and provide an updated Operator Manual and configuration update to correct the CTDI display to all affected systems. Questions should be directed to the contact numbers provided in the letter.

Device

Device Recall HiSpeed FX/I
  • Model / Serial
    With Gantry model numbers 2200997, 2200997-2, 2201000, 2201000-2, 2249696 and 2249696-2.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    HiSpeed FX/I (2201000-2 with Gantry mo. #2249696-2)
  • 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