Events

Recall of SYNGO IMAGING - SYSTEM IUK

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

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
    139389
  • Event Risk Class
    III
  • Event Initiated Date
    2010-06-25
  • 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 malfunction and hence hazard to patients when using syngo imaging version lines vb20 vb30 vb35 in combination with ris (radiology information system) that is violating dicoms (digital imaging and communication in medicine) standard by creating non-unique study instance uids (unique identifier).

Device

SYNGO IMAGING - SYSTEM IUK
  • Model / Serial
    Model Catalog: 10 014 063 (Lot serial: 1262); Model Catalog: 10 014 063 (Lot serial: 1200); Model Catalog: 10 014 063 (Lot serial: 1094)
  • Product Description
    SYNGO IMAGING
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC