Events

Recall of Device Recall Siemens Syngo Imaging XS is a Picture Archiving and Communication System (PACS)

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
    72838
  • Event Risk Class
    Class 2
  • Event Number
    Z-0550-2016
  • Event Initiated Date
    2015-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142336
  • 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 the syngo workflow slr system with software ver: vb10c: printouts may be printed in incorrect anatomical size when using syngo imaging xs filming application in conjunction with a printer not released for anatomical print usage. this may happen due to an invalid combination of printer and the syngo imaging xs printer configuration file.
  • Action
    11/17/2015, CSAN sent to customers with a list of suitable printers for the anatomical printing.

Device

Device Recall Siemens Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
  • Model / Serial
    Model number 10558586  Software version VB10C
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL ; CA ; CO ; CT ; FL ; GA ; IA ; IL ; IN ; KS ; MD ; MI ; MO ; NC ; NE ; NJ ; NV ; NY ; OH ; PA ; TN ; TX ; WI ;
  • Product Description
    Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA