Events

Recall of Dimension RxL Reagent Management System (RMS) Power Cord Plug; An in vitro diagnostic medical device (IVD)

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

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-2012-RN-00699-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00699-3
  • 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
    Partial insertion of the power cord on the rms power input module can cause the plug to overheat and potentially create a fire hazard. dimension reagent management systems without a power cord retention clip may be affected.
  • Action
    Siemens is providing work around instructions for users to implement until a permanent RMS power cord retention clip can be fitted.

Device

Dimension RxL Reagent Management System (RMS) Power Cord Plug; An in vitro diagnostic medical dev...
  • Model / Serial
    Dimension RxL Reagent Management System (RMS) Power Cord Plug; An in vitro diagnostic medical device (IVD)Model Numbers: 10444832, 10444833 and 10453482Manufactured prior to April 24th 2007 Serial Numbers: 99060001-99062554
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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