Events

Recall of Device Recall Siemens syngo Dynamics

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
    46823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1751-2008
  • Event Initiated Date
    2008-02-08
  • Event Date Posted
    2008-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68308
  • 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
    Picture archiving and communication system - Product Code LLZ
  • Reason
    Incorrect data: a software bug may result in a transfer of patient demographic data to a different patient's file.
  • Action
    Siemens issued a customer safety advisory to users on 2/8/08 advising them of the problem and instructing them to complete and verify that the report is locked before opening and reporting on a second patient, and that a software patch will be available Spring 2008.

Device

Device Recall Siemens syngo Dynamics
  • Model / Serial
    All units with version 6.0 software.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution: Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Missouri, Montana, North Carolina, Texas and Utah.
  • Product Description
    Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
  • 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