Events

Recall of Biograph mCTS 64

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
    53453
  • Event Risk Class
    Class 2
  • Event Number
    Z-0164-2010
  • Event Initiated Date
    2009-08-11
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85552
  • 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
    In the unlikely event that the device is modified to operate in the tilted position, the telescoping support mechanism will not engage properly.
  • Action
    Siemens Medical Solutions USA, Inc. issued an "Urgent Field Correction - Recall" notice to consignees by letter dated September 3, 2009 informing them of the problem and that a Siemens service representative will be in contact shortly to service the affected product. For further information, contact Siemens at 1-800-888-7436.

Device

Biograph mCTS 64
  • Model / Serial
    serial numbers: 1002 and 1003
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (IL and OH), Germany, France and Hong Kong.
  • Product Description
    Siemens Biograph mCT-S 64, model number 10248672. || Medical Imaging Equipment.
  • 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