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 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
    24613
  • Event Risk Class
    II
  • Event Initiated Date
    2016-02-01
  • 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 is notifying customers using syngo imaging studio / advanced studio version vb36c and older of the possibility of incorrect values for distance measurement. for measurement calculation syngo imaging vb36c and older version use the dicom attribute "imager pixel spacing" (tag (0018 1164))instead of "pixel spacing" (tag (0028 0030)). this may result in incorrect values for distance measurements. this happens if both dicom attributes "imager pixel spacing" and "pixel spacing" are set and have different values.

Device

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

Manufacturer

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