Events

Recall of Device Recall Siemens

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
    68769
  • Event Risk Class
    Class 2
  • Event Number
    Z-2111-2014
  • Event Initiated Date
    2014-06-30
  • Event Date Posted
    2014-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128627
  • 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 has become aware of the potential malfunction when using syngo imaging xs, version va70a or higher. in some cases a miscalculation may occur for the grey scale values in the functions region of interest, pixel lens, edge enhancement and histograms. this potential malfunction may occur for images with a pixel depth greater than 12 bit. all values calculated for images with a pixel d.
  • Action
    Siemens sent a Customer letter dated June 30th, to all affected customers to inform them of a new software version VA70B_0114 that will be introduced to all syngo Imaging XS customers with version VA70A or higher to solve a potential issue regarding miscalculations done for the grey scale values in the functions "Region of Interest", "Pixel Lens", "Edge Enhancement", and "Histograms". For questions regarding this recall call 610-219-6300.

Device

Device Recall Siemens
  • Model / Serial
    model number: 10496279
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Siemens syngo Imaging XS, version VA70A or higher || Syngo Imaging XS is 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. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced post processing applications.
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA