Events

Recall of Device Recall SOMATOM Sensation CT Systems

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
    34995
  • Event Risk Class
    Class 2
  • Event Number
    Z-0797-06
  • Event Initiated Date
    2006-03-17
  • Event Date Posted
    2006-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45095
  • 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, X-Ray, Tomography, Computed - Product Code JAK
  • Reason
    Firm became aware of a potential problem that could affect scan results and require patient exam to be repeated when using the customized ecg-gated scan protocols in the ct2006a and ct2006g software of their somatom sensation ct systems.
  • Action
    Firm has issued an advisory letter (3/28/2006) to affected customers per Update Instructions CT008/06/S. This letter informs customers about the potential problem and provides instructions to avoid this issue. A Siemens Service Engineer will visit affected sites to hand-deliver this letter and to delete any affected scan protocols, which can then be replaced with default protocols or with new customized protocols.

Device

Device Recall SOMATOM Sensation CT Systems
  • Model / Serial
    Sensation 10 model number 7543015, Sensation 16 model number 7393114, Sensation 64 model number 8377520, and Sensation Open model number 8872017. Software versions CT2006A and CT2006G.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. Product was distributed to medical facilities in AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL IN, KS, KY, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, PA, SC, TX, UT and WI.
  • Product Description
    SOMATOM Sensation CT Systems
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA