Events

Recall of Device Recall Siemens syngo Dynamics Workplace, version 5.0

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
    49457
  • Event Risk Class
    Class 2
  • Event Number
    Z-0544-2009
  • Event Initiated Date
    2008-07-23
  • Event Date Posted
    2009-01-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73470
  • 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
    Image Processing Radiological System - Product Code LLZ
  • Reason
    If the text is manually modified and additional phrases added as a result of worksheet interactions, some of the phrases may not populate the report.
  • Action
    Consignees were notified of the problem via a Customer Safety Advisory Notice dated 7/23/08, which provided guidance on how to minimize the risk of the problem occurring, and told customers that a service patch will be installed when it becomes available.

Device

Device Recall Siemens syngo Dynamics Workplace, version 5.0
  • Model / Serial
    All units.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. || 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