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
    70596
  • Event Risk Class
    Class 2
  • Event Number
    Z-1354-2015
  • Event Initiated Date
    2015-02-18
  • Event Date Posted
    2015-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134102
  • 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
    Possibly incomplete archived studies during pre-fetch. in a server farm setup, when pre-fetch/retrieve operation is performed for partially archived studies, the series that have not yet been archived, will remain unarchived.
  • Action
    Safety Advisory Notice, dated February 18, 2015, was sent to end users that identified the product, problem, and action to be taken. Users were advised not to manually remove the delete protection in the STS.

Device

Device Recall Syngo.plaza
  • Model / Serial
    Model Numbers of device: 10592457, 10863172, serial numbers: 100177 100033 100181 100029
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution: MA, WI, FL
  • Product Description
    Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.
  • 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