Events

Recall of Device Recall System, Image Processing Radiological

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
    73481
  • Event Risk Class
    Class 2
  • Event Number
    Z-1232-2016
  • Event Initiated Date
    2016-02-24
  • Event Date Posted
    2016-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144271
  • 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
    After importing, the segmentation results appear mirrored at the carto system and can't be used for the ablation procedure.
  • Action
    Siemens sent an Important Customer Safety Notice dated February 24, 2016, to all affected customers notifying them that the issue will be remedied with a software update via AX004/16/S. Following the installation of this update, the segmentation results can be used at the CARTO system as described in the operator manual. Customers with questions were instructed to call 800-888-7436. For questions regarding this recall call 610-448-6461.

Device

Device Recall System, Image Processing Radiological
  • Model / Serial
    Serial # 20119, 20098, 20041, 20124, 12177, 20026
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IL, NY, MT, and MN.
  • Product Description
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. || .
  • 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