Events

Recall of UROSKOP OMNIA

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
    48072
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-28
  • 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
    1.) during a rad examination with automatic exposure control a highly unlikely malfunction can result in longer radiation exposure than required. this may also result in an overexposed image that is not of diagnostic quality resulting in the examination needing to be repeated. statistically this malfunction only occurs once every 7000 images and only if images are taken in automatic exposure mode. the automatic exposure control is used less frequently with the uroskop omnia therefore reducing the risk that such malfunction might occur. 2.) when selecting a tomo ogp in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own. 3.) sporadically it may occur that the radiation is not activated and therefore an exposure is performed without radiation. in case of a scan sequence at luminos drf the complete sequence might have to be repeated.

Device

UROSKOP OMNIA
  • Model / Serial
    Model Catalog: 10094910 (Lot serial: S/N 3071); Model Catalog: 10094200 (Lot serial: 16 UNITS CONTACT MFR FOR S/N)
  • Product Description
    UROSKOP OMNIA
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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