Events

Recall of Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd.

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
    RC-2013-RN-00111-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-02-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00111-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    There is potential for malfunction in cases where the table vertical tilt movement is obstructed by a solid object resulting in a collision. this can result in damage to the system mechanics that may not necessarily prevent the table from functioning immediately, but can lead to complete failure of the table mounting mechanics. in this case, the table may drop resulting in potentially hazardous situations for patients and/or staff.
  • Action
    Siemens is advising customers to avoid any collision of the table with objects in the table's operating area. Customers should contact their Siemens service representative for a precautionary inspection should such a collision occur or have occurred in the past.

Device

Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Lu...
  • Model / Serial
    Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos RHD, Luminos RF Classic, Luminos Fusion, Luminos Select (Fluoroscopic diagnostic x-ray systems)ARTG Numbers: 102181 & 144246
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA