Events

Recall of Device Recall syngo.plaza VA20A, model number 10592457

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
    60761
  • Event Risk Class
    Class 2
  • Event Number
    Z-0827-2012
  • Event Initiated Date
    2011-05-01
  • Event Date Posted
    2012-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106410
  • 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
    The firm has become aware of the potential for an unintended merge of multiple patients when using syngo.Plaza version va20 with server farm setup integrated to a ris. sporadically it can happen that certain patient ids in the database are deleted and sent to null. this can cause incorrect merging with patients that already had a null patient id.
  • Action
    The firm initiated their product recall in May 2011 by issuing a "Customer Safety Advisory Notice" informing all customers of the malfunction and providing instructions on how to avoid the error. The issue will be solved with the next version release, planned for June 2011.

Device

Device Recall syngo.plaza VA20A, model number 10592457
  • Model / Serial
    Model number 10592457, serial numbers 100174, 100177, and 100181.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - Including the states of Florida, Massachusetts and Wisconsin.
  • Product Description
    Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
  • 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