Events

Recall of Symbia E and e.cam collimator (nuclear imaging 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-00330-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00330-1
  • 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
    Siemens have received complaints regarding incidents where collimator change activities have resulted in operator injury. the investigation found that these incidents may have been avoided by operators properly following specified instructions. the system was designed to safely store and exchange collimators, however if the instructions are not followed serious injuries, such as broken bones and lacerations, may occur. siemens have determined that although the existing user manual is correct, additional supplemental instructions, with the inclusion of visual aids, may further clarify and emphasise the proper collimator change process.
  • Action
    Siemens is providing users with addendum instructions to follow during collimator change activities. This action has been closed-out on 27/01/2017.

Device

Symbia E and e.cam collimator (nuclear imaging gamma camera system)
  • Model / Serial
    Symbia E and e.cam collimator (nuclear imaging gamma camera system)Catalogue Numbers: 10275879, 10413009, 04380213, 04380221, 05242826, 05977066, 05977074, 05984005, 05989079, 05989087, 05989095, 05991109, 05991117, 05992099, 07324119, 07324135, 07324143, 07324150, 07760809, 07760932, 07761161, 07823920, 07823938, 07823946, 07823953, 07823961, 07823979, 10151531, 10151532, 10520745ARTG Number: 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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