Events

Recall of Biograph mCT and Biograph mCT Flow

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-2016-RN-01650-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01650-1
  • 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
    An issue has been identified that the light marker windows used for the positioning laser and integrated into the front cover of the biograph mct or biograph mct flow system may loosen and potentially drop out. in this case, there is a risk that a person could touch the electrical or rotating parts of the gantry in the unlikely event that they reach through the window opening. this could result in a serious injury such as electrical shock or physical harm. there have not been any reports of complaints regarding this issue.
  • Action
    Siemens is advising users to conduct a visual inspection of their Biograph mCT or Biograph mCT Flow and that in the event that the light market window is missing or loose, they should not use the Biograph mCT or Biograph mCT Flow and should immediately contact their local Siemens Customer Service Engineer for correction of the problem.

Device

Biograph mCT and Biograph mCT Flow
  • Model / Serial
    Biograph mCT and Biograph mCT FlowCatalogue/Lot numbers: 10248668, 10248669, 10248670, 10248671, 10248672, 10248673, 10250743, 10250745, 10507786, 10528955, 10529159ARTG number: 144218
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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