Events

Recall of Device Recall SOMATOM CT System

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
    34872
  • Event Risk Class
    Class 2
  • Event Number
    Z-0796-06
  • Event Initiated Date
    2006-03-09
  • Event Date Posted
    2006-04-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45543
  • 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
    When using the lungcare feature in the somatom ct systems some marks made on ct images may not be saved.
  • Action
    The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.

Device

Device Recall SOMATOM CT System
  • Model / Serial
    Sensation Open model number 8872017 with serial numbers 49208, 49311, 49207, 49307 and 49330
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
  • Product Description
    SOMATOM CT System Sensation Open. Computed tomography x-ray system.
  • 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