Events

Recall of Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molecular

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cti Pet Systems Inc.

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
    27358
  • Event Risk Class
    Class 2
  • Event Number
    Z-0106-04
  • Event Initiated Date
    2003-10-02
  • Event Date Posted
    2003-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29741
  • 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, Tomography, Computed, Emission - Product Code KPS
  • Reason
    Cps has found that in some instances, when the ct e-stop is activated, a malfunction may occur where the phs controller may not shut down and stop bed motion.
  • Action
    Written notification was sent out beginning 10/02/2003 to distributors and end users to advise them of the problem.

Device

Device Recall Biograph PET/CT, dist by Siemens Medical Solutions & Reveal PET/CT, dist CTI Molec...
  • Model / Serial
    All CPS manufactured PET/CT systems distributed between October 31, 2000 and June 24, 2003.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
  • Product Description
    Siemens Models: BIOGRAPH, BIOGRAPH LSO and CTI Models: REVEAL HD, REVEAL RT
  • Manufacturer
    Cti Pet Systems Inc

Manufacturer

Cti Pet Systems Inc
  • Manufacturer Address
    Cti Pet Systems Inc, 810 Innovation Drive, Knoxville TN 37932-2571
  • Source
    USFDA