Events

Recall of MAGNUS Hybrid OR table column 1180.01B2

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia 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-00466-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-06-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00466-1
  • 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
    Maquet have been made aware of a complaint regarding a reported collision between the c-arm of the angiography-system and the magnus or table system. the root cause analysis has shown that the magnus column provided the wrong position data for the longitudinal movement. thus the collision calculation of the angiography-system led to an incorrect result. it was diagnosed that the magnus or table system may provide incorrect position data for particular movements in very rare cases after switching on the angiography-system. if this occurs, the system at the latest operates properly again after activating the corresponding movement.
  • Action
    A MAQUET service technician will be contacting users to arrange an appointment to update the software free of charge. Until that occurs users should activate all movements of the OR table system for a short time after switching on the angiography-system. The operator always has to observe the movement of the C-arm to have the possibility to react early enough if required.

Device

MAGNUS Hybrid OR table column 1180.01B2
  • Model / Serial
    MAGNUS Hybrid OR table column 1180.01B2Serial number 00001 to 00100
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA