Events

Recall of e.cam system (Nuclear medicine gamma camera system )

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-00281-2
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00281-2
  • 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 that refurbished e.Cam systems have been delivered to users without the full user documentation. the training provided to users provides the necessary cautions and warnings; however these manuals provide additional instructions and reference materials necessary for the safe and proper operation of the systems.
  • Action
    Siemens is providing users with the full instruction manual.

Device

e.cam system (Nuclear medicine gamma camera system )
  • Model / Serial
    e.cam system (Nuclear medicine gamma camera system )Catalogue Number: 10151532ARTG Number: 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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