Events

Recall of Device Recall Syngo

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
    79178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0808-2018
  • Event Initiated Date
    2017-08-31
  • 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=161520
  • 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
    A software update was released on august 22, 2017. performing this software installation and upgrading syngo.Via system to the software version vb20a_hf02 will resolve various bugs and inconsistent diagnosis with the old system.
  • Action
    On August 25, 2017 an URGENT letter was issued to customers notify of a system update for Syngo.via systems with SW VB20A. The software was released on August 22, 2017. Several bugs and inconsistent diagnoses were detected and this software is intended to correct these. If you have any questions, call Siemens Customer Care Centre at 888-826-9702 (24/7).

Device

Device Recall Syngo

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