Events

Recall of Device Recall SYNGO IMAGING (VERSION V30 and V31)

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
    71507
  • Event Risk Class
    Class 2
  • Event Number
    Z-1972-2015
  • Event Initiated Date
    2015-06-11
  • Event Date Posted
    2015-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138013
  • 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
    During certain clinical workflows safety issues may occur involving monitor assignment order and incorrect display and measurements for images with non square pixel size.
  • Action
    Siemens sent a Customer Advisory Notice, dated June 11, 2015, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were also asked to check the software version and consider whether the issue impacts clinical routine and if a software update is necessary.

Device

Device Recall SYNGO IMAGING (VERSION V30 and V31)
  • Model / Serial
    model number: 10014064 serial numbers: 5846 5847 4333 4334 4335
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US in the states of NC and NE
  • Product Description
    SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
  • 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