Events

Recall of Device Recall Syngo Imagaing

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
    46318
  • Event Risk Class
    Class 2
  • Event Number
    Z-0732-2008
  • Event Initiated Date
    2007-11-27
  • Event Date Posted
    2008-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67179
  • 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
    Radiological Image Processing System - Product Code LLZ
  • Reason
    Inconsistent data - a buffer overflow may occur between information system and picture system if the system experiences a high load. (e.G. ris/pacs communication is unusally high).
  • Action
    The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.

Device

Device Recall Syngo Imagaing
  • Model / Serial
    Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.
  • Product Description
    Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
  • 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 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA