Events

Recall of Device Recall SIEMENS SOMATOM Force

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
    70556
  • Event Risk Class
    Class 2
  • Event Number
    Z-1267-2015
  • Event Initiated Date
    2015-02-06
  • Event Date Posted
    2015-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134030
  • 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
    Possibility of image artifacts during data acquisition when using adaptive cardio sequence, turbo flash, and head modes. the update improves system start-up behavior and resuming, ecg handling with visual feedback of correct placement of ecg leads and contact quality, and other safety related issues.
  • Action
    Siemens sent a Customer Advisory Notice dated February 6, 2015, to all customers via USPS Certified Mail. The notice identified the affected product, problem and actions to be taken.

Device

Device Recall SIEMENS SOMATOM Force
  • Model / Serial
    Model number: 10742326, with serial numbers: 75454, 75464, 75437, 75475, 75481, 75439, 75450, 75460, 75476, 75458, 75467, 75478.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of PA, MA, MN, NY, SC, MD, NY, IL, OH, TX and KY.
  • Product Description
    SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0; Computed tomography system. || Product Usage: The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Mail Code: 65-1A, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA