Events

Recall of Device Recall Leonardo Workstations with software version 2022A/B, 2003A

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
    26218
  • Event Risk Class
    Class 3
  • Event Number
    Z-1088-03
  • Event Initiated Date
    2003-02-28
  • Event Date Posted
    2003-08-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27287
  • 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, Image Processing, Radiological - Product Code LLZ
  • Reason
    Software problem this error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.
  • Action
    The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

Device

Device Recall Leonardo Workstations with software version 2022A/B, 2003A
  • Model / Serial
    Model 7129534, Serial # 01001 through 01380, 05001 through 05600, and 10001 through 10320
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.
  • Product Description
    Leonardo Workstations with software version 2022A/B, 2003A
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Parkway, Malvern PA 19355
  • Source
    USFDA