Events

Recall of Device Recall GE Revolution CT computed tomography xray systems

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare.

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
    70133
  • Event Risk Class
    Class 2
  • Event Number
    Z-0955-2015
  • Event Initiated Date
    2014-11-12
  • Event Date Posted
    2015-01-26
  • 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=132293
  • 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
    A required quality control test was not performed during installation associated with the software of the revolution ct scanner.
  • Action
    GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Device

Device Recall GE Revolution CT computed tomography xray systems
  • Model / Serial
    Software version: 14MW14.29
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of CA, FL, IL, NY, UT and WA.
  • Product Description
    The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.
  • Manufacturer
    GE Healthcare

Manufacturer

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