Events

Recall of MAGNETOM Combi Dockable Neurosurgery Table

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-01360-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-10-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01360-1
  • 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
    It has been identified that due to a potential manufacturing error, in some cases a potential exists for a sudden drop in table height. this can happen with or without user interaction. the maximum drop in height is 5cm. it is therefore necessary to verify whether the tables are affected and carry out any required corrections.
  • Action
    Siemens is requesting that users do not use the system until it has been inspected by a Siemens Customer Service Engineer. Further information about the use of system and the necessary corrections will be provided at the time of inspection. Siemens will contact affected users shortly to arrange a suitable inspection time. This action has been closed-out on 27/02/2017.

Device

MAGNETOM Combi Dockable Neurosurgery Table

Manufacturer

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