Events

Recall of Device Recall Acuson/Sonovista X300

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
    49411
  • Event Risk Class
    Class 2
  • Event Number
    Z-0086-2009
  • Event Initiated Date
    2008-08-19
  • Event Date Posted
    2008-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73273
  • 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
    diagnostic ultrasound - Product Code IYN
  • Reason
    Incorrect value calculations by the device may result in inaccurate aortic stenosis estimates.
  • Action
    Siemens initiated a Field Correction 08/19/2008. Service personnel will conduct a site visit and distribute a Customer Safety Advisory Notice, correct the problem and install a revised software version.

Device

Device Recall Acuson/Sonovista X300
  • Model / Serial
    Sonovista: 10133170 (Japan only) Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837).  Software revisions 1.0.06 and 1.0.07 for Sonovista X300 and 1.0.08 for Acuson X300
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Singapore, Germany, Denmark, Romania, Sweden, Poland, Portugal, Australia, Chile, India, Spain, Thailand, Malaysia, South Africa, Hungary, Saudi Arabia, Qatar, Peru, Italy, Azerbaijan, Greenland, Austria, Venezuela, Puerto Rico, Brazil and Japan.
  • Product Description
    Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions Sonovista X300 software revision 1.0.06 and 1.0.07, Acuson X300 sofware revision 1.0.08 ultrasound system with onscreen display.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94039-7393
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA