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
    29256
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-19
  • 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
    Potential issue when using syngo.Plaza or syngo imaging xs and anatomical printing. anatomical printouts may not be printed in correct anatomical size. printouts may be printed in incorrect anatomical size when using syngo.Plaza or syngo imaging xs filming application to print in anatomical size with a printer not released for anatomical print. this may happen due to an invalid combination of printer and the syngo.Plaza or syngo imaging xs printer configuration file. printers which are marked in the attached list with "yes" for anatomical printing will not be affected by this issue. only these printers are validated to be used for anatomical printing.

Device

SYNGO.PLAZA
  • Model / Serial
    Model Catalog: 10592457 (Lot serial: 100086); Model Catalog: 10592457 (Lot serial: 100168); Model Catalog: 104 96 279 (Lot serial: 3028); Model Catalog: 104 96 279 (Lot serial: 3127); Model Catalog: 075 020 29 (Lot serial: 9749); Model Catalog: 075 020 29 (Lot serial: 11614); Model Catalog: 075 020 29 (Lot serial: 13357); Model Catalog: 10592457 (Lot serial: 100008); Model Catalog: 10592457 (Lot serial: 100001); Model Catalog: 10592457 (Lot serial: 100102); Model Catalog: 10592457 (Lot serial: 100018)
  • Product Description
    Syngo.Plaza
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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