Events

Recall of Device Recall ECAT EXACT HR 47

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA 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
    45154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0272-2008
  • Event Initiated Date
    2007-07-23
  • Event Date Posted
    2007-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64983
  • 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
    Tomography Computed Emission System - Product Code KPS
  • Reason
    Incorrect decay correction results - ecat system's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissions followed by all emissions.
  • Action
    Siemans sent an Urgent Device Correction letter, dated June 15, 2007, to all affected consignees informing the user of the problem and requesting that they discontinue the practice of running all transmissions followed by all emissions until a corrective software patch is installed. The corrective software patch is expected to be installed by October 2007.

Device

Device Recall ECAT EXACT HR 47
  • Model / Serial
    Serial Numbers: 3600041-00-0001001, 3600050-000001, 3600050-00-0001001, 3600050-00-0001002, 3600050-00-0001004, 3600059-00-0001001, 3600059-00-0001002, 3600059-00-0001006
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and Countries of Argentina, Austria, Belgium, Brazil, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Italy, Japan, South Korea, Netherlands, Norway, Saudi Arabia, Sweden, Slovak Republic, Turkey, and Taiwan.
  • Product Description
    Siemens ECAT EXACT HR 47, Catalog No. 2956261, PET/CT Scanner, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534
  • Manufacturer
    Siemens Medical Solutions USA Inc

Manufacturer

Siemens Medical Solutions USA Inc
  • Manufacturer Address
    Siemens Medical Solutions USA Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA