Events

Recall of Device Recall Siemens syngo.plaza

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
    62462
  • Event Risk Class
    Class 2
  • Event Number
    Z-2078-2012
  • Event Initiated Date
    2012-02-24
  • Event Date Posted
    2012-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110712
  • 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
    Siemens became aware of a potential malfunction when using syngo.Plaza with software version va20c_hf01. for datasets with distance measurements it can happen, that all images are not loaded to viewer but no error message is displayed to user.
  • Action
    Siemens sent a Customer Safety Advisory Notice letter dated February 24, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to ensure that the prefix defined in the viewer settings for "Content Creator's Initials" is not empty. Then all images will be display correctly. This has to be checked for every user. Further questions please call 610-219-6300.

Device

Device Recall Siemens syngo.plaza
  • Model / Serial
    Model number 10592457
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    (USA) nationwide including the states of CA, FL, GA, MA, MN, MO, NJ, NY, OH, WA, and WI.
  • Product Description
    Siemens syngo.plaza. || Radiological image processing system
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA