Events

Recall of Device Recall Leonardo Workstation

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
    46360
  • Event Risk Class
    Class 2
  • Event Number
    Z-1038-2008
  • Event Initiated Date
    2007-12-21
  • Event Date Posted
    2008-04-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67280
  • 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
    x-ray image archiving system - Product Code LLZ
  • Reason
    Incorrect display: the orientation labels will be incorrectly displayed on the reconstructed inspace 3-d image if the orientation was not originally hfs on the acquisition system.
  • Action
    Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software.

Device

Device Recall Leonardo Workstation
  • Model / Serial
    Model Number: 7129534. Serial Numbers: 10483, 10651, 10628, 10488, 10605, 10676, 10658, 10421, 10685, 10724, 10584, 10619, 10626, 10629, 10635, 10694, 10706, 10438, 10600, 10668, 10655, 10436, 10606, 10702, 10433, 10558, 10636, 10642, 10692, 10698, 10412, 10440, 10539, 10613, 10674, 10621, 10634, 10583, 10684, 10476, 10414, 10664, 10671, 10712, 10472, 10567, and 10641. Software version VB30B.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
  • 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