Events

Recall of Device Recall Siemens syngo.plaza Radiological Image Processing System

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
    63521
  • Event Risk Class
    Class 2
  • Event Number
    Z-0465-2013
  • Event Initiated Date
    2012-06-20
  • Event Date Posted
    2012-12-03
  • 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=114137
  • 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
    Firm has become aware of an unintended behavior when using syngo.Plaza and issued an update instruction. the update instruction sy050/12/s provides a software update and addresses the following issues: - patient rename messages for the same patient are being continually processed for several days. this fills up the 'pcvdbsrv' log and potentially affects performance of the system. - data could.
  • Action
    The firm, Siemens, sent "Update Instruction SY050/12/S" on June 20, 2012 to its consignees/customers. The Update Instructions described the product, problem and actions to be taken. It also provides a software update. If you have any questions call 610-219-4834 or email: anastasia.mason@siemens.com.

Device

Device Recall Siemens syngo.plaza Radiological Image Processing System
  • Model / Serial
    Model number 10 592 457
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, FL, GA, MA, MN, MO, NJ, NY, OH, and WI.
  • Product Description
    Siemens syngo.plaza Radiological Image Processing System || Usage: 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