Events

Recall of Device Recall Biograph mCT Flow Edge4R

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
    69897
  • Event Risk Class
    Class 2
  • Event Number
    Z-0807-2015
  • Event Initiated Date
    2014-11-13
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131919
  • 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
    Possibility for system display freeze during ct interventional procedures.
  • Action
    The firm initiated their recall by certified mail on 11/13/2014.

Device

Device Recall Biograph mCT Flow Edge4R
  • Model / Serial
    Serial Numbers: 11002, 11005, 11006, 11008
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of NC and MA and the countries of Australia, Canada, Switzerland, and Germany.
  • Product Description
    Biograph mCT Flow Edge-4R, System Material Number 10528955. || The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA