Events

Recall of SYNGO.PLAZA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    133420
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    When using syngo.Plaza sw version va20 with mammography license there are two dicom attributes defined to store the laterality information in the image header-dicom tag "laterality" (00200060) and dicom tag "image laterality" (00200062). for the display and hanging of mammography images syngo.Plaza uses the dicom tag "image laterality" (00200062). if a digital mammography system only provides the dicom tag "laterality" (00200060) by default syngo.Plaza will not display this information in the image text. in addition these images may not be properly aligned to mammography segments.

Device

SYNGO.PLAZA
  • Model / Serial
    Model Catalog: 10592457 (Lot serial: 100461)
  • Product Description
    SYNGO.PLAZA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC