Events

Recall of 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
    75594
  • Event Risk Class
    Class 2
  • Event Number
    Z-0692-2017
  • Event Initiated Date
    2016-10-20
  • Event Date Posted
    2016-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150867
  • 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
    Siemens is providing software update version va50a_sp3 to address the software bugs that were identified through normal field monitoring and the global complaint handling process. correction for the problems are as follows: 1. correction to volumetric misrepresentations of high contrast objects when using admire. 2. correction to highly sporadic scan aborts due to temporarily tube currents at 0ma. 3. correction to missing microsoft hotfixes (ms16-001, ms15-135, ms15-088, ms15-048). 4. correction to highly sporadic image artifacts caused by error signals from high voltage chain at extremely high tube currents. 5. correction to highly sporadic incomplete image reconstruction due to temporary slow hard disk write speed. 6. correction to highly sporadic scan aborts due to temporarily high disk load of system disk. 7. correction to highly sporadic image artifacts generated by scatter correction in case of tube arcings.
  • Action
    Siemens sent a Customer Information Letter dated November 2, 2016, to customers affected by the recall to inform them of a release of a software update that will provide bug-fixes to improve system performance. Customers will be contacted to arrange a date for onsite installation. For further questions, please call (610) 448-6471.

Device

Siemens SOMATOM Force
  • Model / Serial
    Model Number 10742326, Serial Numbers: 75708,75709,75607,75617,75550,75526 75512,75567,75536,75711,75514,75600,75563,75510,75454,75540,75571,75500 75527,75475,75535,75481,75482,75710,75460,75476,75588,75493,75458,75528 75467,75602,75487,75464,75478,75604,75513,75532,75555,75524,75515,75559 75610,75501,75570,75616,75576,75605
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    SOMATOM Force, System x-ray, tomography, computed
  • 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