Events

Recall of ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: || ¿ Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL || ¿ CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL || ¿ Marconi Models: Magellan || ¿ Hitachi Models: Sceptre and Sceptre XL

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
    25710
  • Event Risk Class
    Class 2
  • Event Number
    Z-0674-03
  • Event Initiated Date
    2003-03-04
  • Event Date Posted
    2003-03-21
  • 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=26344
  • 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
    Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
  • Action
    Written notification was sent via letter with corrective software beginning on March 4 to the end users.

Device

ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emis...
  • Model / Serial
    All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile
  • Product Description
    ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: || ¿ Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL || ¿ CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL || ¿ Marconi Models: Magellan || ¿ Hitachi Models: Sceptre and Sceptre XL
  • 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