Events

Recall of Device Recall Syngo XWorkplace

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
    72751
  • Event Risk Class
    Class 2
  • Event Number
    Z-0597-2016
  • Event Initiated Date
    2015-11-18
  • Event Date Posted
    2016-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142124
  • 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
    Potential post-processing software issue when using tabcard "4d" on x-workplace with software version vd10e. a too small measurement in the mprs of a volume when images are acquired with a ct scanner with a tilted gantry. in a 2x2 layout, the 4d tabcard will show an incorrect, too small length measurement. this could result in selecting a device of the wrong size, which then needs to be exchanged.
  • Action
    Siemens sent an Important Customer Safety Notice dated November 17, 2015. The Notice identified the product, the problem, and the action to be taken by the customer. The potential issue will be remedied with a software update via Update Instructions AX067/15/S. Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers with questions were advised to call 800-888-7436.

Device

Device Recall Syngo XWorkplace
  • Model / Serial
    Software Version: SW VD-10E
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including: AL, AZ, CA, CO, FL, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NC, NY, OH, OK, PA, SC, TN, TX, VA, and WI.
  • Product Description
    Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
  • 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