Events

Recall of SYNGO.VIA

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
    53207
  • Event Risk Class
    III
  • Event Initiated Date
    2012-10-10
  • 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
    Siemens has identified a potential malfunction when using syngo.Via version va11a_hf02 and higher. this malfunction occurs only with static and wholebody nuclear medicine images. in this case it can happen that the orientation lables at the segment borders are in conflict with the view name in the image text which has been entered by the user.

Device

SYNGO.VIA
  • Model / Serial
    Model Catalog: IVK 104 96 180 (Lot serial: 101075); Model Catalog: IVK 104 96 180 (Lot serial: 101132); Model Catalog: IVK 104 96 180 (Lot serial: 101142); Model Catalog: IVK 104 96 180 (Lot serial: 101464); Model Catalog: IVK 104 96 180 (Lot serial: 100775); Model Catalog: IVK 104 96 180 (Lot serial: 101511); Model Catalog: IVK 104 96 180 (Lot serial: 100861); Model Catalog: IVK 104 96 180 (Lot serial: 100999); Model Catalog: IVK 104 96 180 (Lot serial: 101000); Model Catalog: IVK 104 96 180 (Lot serial: 101471)
  • Product Description
    SYNGO.VIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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