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
    72137
  • Event Risk Class
    Class 2
  • Event Number
    Z-0107-2016
  • Event Initiated Date
    2015-08-18
  • Event Date Posted
    2015-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139933
  • 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
    Software and firmware bugs.
  • Action
    Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner.

Device

Device Recall Siemens SOMATOM Force
  • Model / Serial
    Model Number of device- 10742326  with serial numbers: 75514 75512 75510 75454 75437 75500 75475 75481 75439 75450 75482 75460 75493 75476 75458 75467 75487 75478 75513 75515, and  75501.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    SOMATOM Force; computed tomography x-ray system. || Intended to generate and process cross-sectional images of patients.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

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