Events

Recall of Device Recall Syngo.plaza

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
    73041
  • Event Risk Class
    Class 2
  • Event Number
    Z-0862-2016
  • Event Initiated Date
    2015-12-22
  • Event Date Posted
    2016-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142876
  • 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
    Siemens is releasing an updated software version to address several software issues including rgb images will show "?" since calculation of hu is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen.
  • Action
    Siemens sent a Voluntary Correction and Removal Action letter dated December 30, 2015. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that a software update VB10A_HF01/06 is being released simulataneously to eliminate the issue. Customers with questions were instructed to call 1-888-826-9702.

Device

Device Recall Syngo.plaza
  • Model / Serial
    Device model numbers: 10863171, 10863172, 10863173
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL CA CT FL IN KS LA MA MD MI MN MO MS NE NY OH OR PA TX WA WI
  • Product Description
    Syngo Plaza Picture archiving and communication system. || Software only. || PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems.
  • 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