Events

Recall of Device Recall 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
    62678
  • Event Risk Class
    Class 2
  • Event Number
    Z-2264-2012
  • Event Initiated Date
    2012-07-18
  • Event Date Posted
    2012-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111340
  • 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
    There is a potential malfunction when using syngo imaging xs, version va70a or higher. in some situations it can happen that a miscalculation is done for the grey scale values in the functions "regions of interest", "pixel lens", "edge enhancement" and "histograms".
  • Action
    Siemens sent a "CUSTOMER SAFETY ADVISORY NOTICE" dated July 12, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. For questions concerning this notice contact your local Siemens Service Rep..

Device

Device Recall syngo Imaging XS
  • Model / Serial
    Model number 10496279
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution-CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
  • Product Description
    syngo Imaging XS. || Radiological image processing system.
  • 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