Events

Recall of Device Recall Siemens 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
    65719
  • Event Risk Class
    Class 2
  • Event Number
    Z-1975-2013
  • Event Initiated Date
    2013-03-04
  • Event Date Posted
    2013-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119958
  • 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 issued a customer safety notice to inform customers of a potential problem when using syngo.Plaza. in some instances, it can happen that the laterality information in mammography images is not displayed and these images may not be properly aligned to mammography segments.
  • Action
    The firm, Siemens, notified their customers on March 4, 2013 and sent a "Customer Safety Advisory Notice" letter dated April 03, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to always check whether the laterality information is displayed in the image text of mammography images; if not, the DICOM header is accessible and can be checked for the tag "Laterality" (0020, 0060). If a system is not able to provide the DICOM tag "Image Laterality" (0020, 0062), configuring the image text by adding the tag was proposed. If you have sold the device/equipment and it is no longer in your possession, forward this safety notice to the new owner of the device/equipment and inform us about the new owner of the device/equipment. This issue will be resolved in the syngo.plaza software version VA20D_HF04 which is planned to be released in 02/2013. Customers were also instructed to contact the local Siemens service office to plan the update. If you have any questions, contact the SYNGO CEO or Vice President Quality at +49 (9131) 84-4874 or email to: michael.mlb.braun@siemens.com.

Device

Device Recall Siemens syngo.plaza
  • Model / Serial
    Model number 10592457, serial numbers 100219, 100201, 100473. Update dated 5/13/13 included the following additional serial numbers: 100177, 100504, 100174, 100181, 100473, and 100539.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: FL, MA, KS, NY, OH, PA, TX and WI.
  • Product Description
    Siemens syngo.plaza SW version VA20 with Mammography license. || image processing, radiological system
  • 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