Events

Recall of e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)

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-00419-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00419-1
  • 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 has determined that e.Cam or symbia systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. the resulting risk is that the framing of the image data and the calculated ejection fraction values may be lower. although misdiagnosis could be possible if ejection fraction values are used as a sole input to diagnosis. in the lifetime of the product, siemens have received three complaints, none of which led to misdiagnosis or adverse events.
  • Action
    A software patch (Ml16-001) and corresponding operator manual addendum will be implemented. Once the software patch is installed on the affected system, the improvements will further reduce the likelihood of the issue occurring. In the interim, users are advised they may continue to use your system since the probability of occurrence is remote. To reduce the likelihood of this issue, they are advised to perform Daily Shutdown and Start-up as described in the operator manual. This action has been closed-out on 26/05/2017.

Device

e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)
  • Model / Serial
    e.cam and all Symbia systems with foresight detectors (Nuclear medicine gamma camera systems)Catalogue Numbers: 10151532, 8717733, 10275009, 10275010, 10275879, 8717741, 10275008, 10275007, 10764804, 10764803, 10764801, 10764802, 10910501, 10151531ARTG Number: 186317
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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