Events

Recall of Device Recall syngo Dynamics 9.0

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
    58830
  • Event Risk Class
    Class 2
  • Event Number
    Z-2762-2011
  • Event Initiated Date
    2011-05-10
  • Event Date Posted
    2011-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100383
  • 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
    For systems upgraded to syngo dynamics version 9.0, if a legacy report generated by version 3.X or earlier is opened in the version 9.0 portal, the legacy report may be deleted and replaced with a new report from the version 9.0 reporting system or a blank report.
  • Action
    Siemens Medical Solutions, USA, Inc sent a letter entitled "Customer Safety Advisory Notice" to all direct accounts on May 10, 2011. The letter stated the name and version of the software, problem noted, a work-around to be implemented until a service patch is created to fix the problem, and that the letter should be placed in the software's operator's manual to be seen by all who utilize the software.

Device

Device Recall syngo Dynamics 9.0
  • Model / Serial
    Serial numbers 10091602 and 10091604
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    syngo Dynamics Picture Archiving Communication System || The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of digital medical images including quantification and report generation.
  • Manufacturer
    Siemens Medical Solutions, USA, Inc

Manufacturer

Siemens Medical Solutions, USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions, USA, Inc, 400 Morgan Rd, Ann Arbor MI 48108
  • Source
    USFDA