Events

Recall of Syngo Imaging XS

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
    53564
  • Event Risk Class
    Class 2
  • Event Number
    Z-0174-2010
  • Event Date Posted
    2009-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85877
  • 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
    Incomplete amount of image data; specifically, the image count in the series table of the online and archive database will display the full amount of images received at the syngo imaging xs as archived. however, the zip file on the nas or hsm will contain fewer images-those which have been archived until the time of the error/interruption.
  • Action
    The recalling firm issued a "Customer Safety Advisory Notice" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center.

Device

Syngo Imaging XS
  • Model / Serial
    Model number 7502029 - serial number 14086 and Model number 10496279 - serial number 1418
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities in NY and OH
  • Product Description
    Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
  • 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