Events

Recall of Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HM

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2015-RN-01114-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01114-1
  • 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
    Siemens has identified rms refrigeration compressors that are missing the safety cover on the electrical termination block. the exposed electrical hazard on the electrical termination block is located directly behind the rms waste container. the absence of the safety cover results in a potential electrical hazard to the operator. this issue does not impact patient results.
  • Action
    Siemens is providing a safety warning to be placed on the machine as an interim measure. A service engineer will be inspecting all units and installing a cover where required.

Device

Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System ...
  • Model / Serial
    Dimension Integrated Chemistry Systems. Dimension EXL with LMDimension Reagent Management System (RMS) Dimension RxL Max HMCatalogue Numbers: 10472176, 10444833 and 10444829ARTG Number: 174699An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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