Events

Recall of Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2012-RN-01027-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01027-1
  • 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
    A particular component may not have been fitted during the installation of some mavig portegra 2 systems. the component would hold a pin in position in case that pin gets released and thus prevent system parts from becoming loose, leading to an adverse effect on the function and possibly becoming detached from the system.
  • Action
    Siemens is advising users that a technician will perform an update to the affected systems.

Device

Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radia...
  • Model / Serial
    Siemens AX System (Digital fluoroscopicc x-ray system) fitted with MAVIG PORTEGRA 2 System (Radiation protection system)Part Numbers for the MAVIG PORTEGRA 2 System: 7721165, 4787714, 7559375, 10281150, 10281151, 10281152 and 10281153
  • Manufacturer
    Siemens Ltd

Manufacturer

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