Events

Recall of Leonardo

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
    26082
  • Event Risk Class
    Class 2
  • Event Number
    Z-0841-03
  • Event Initiated Date
    2002-10-11
  • Event Date Posted
    2003-05-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27031
  • 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
    Perfusion ct is displaying a higher gray and color values than normal. a software problem.
  • Action
    Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software.

Device

Leonardo
  • Model / Serial
    Model Number 7129534
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO.
  • Product Description
    Leonardo MM-WS systems. System, Image Processing.
  • 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