Events

Recall of Device Recall Syngo.via software

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
    79513
  • Event Risk Class
    Class 2
  • Event Number
    Z-1261-2018
  • Event Initiated Date
    2018-01-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162538
  • 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
    When the archiving configuration is changed, data received/created after the upgrade may be flagged as "not to be archived". this is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. due to the disabled cleanup function, disc capacity for free space decreases faster than usual. unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
  • Action
    Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.

Device

Device Recall Syngo.via software
  • Model / Serial
    All Syngo.via systems with VB20A. Model number 10496180.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical device software which needs to be installed.
  • Product Description
    Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
  • 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