Events

Recall of Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging 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-2014-RN-01113-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01113-1
  • 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 received reports of unintended radial motion of the detectors. this unintended motionmay cause the patient, compression related injuries. the symbia s or t system has been designed to detect such faults and automatically shut down. if the system shuts down with the message "system requires service, please contact your customer service representative" the system will be disabled until the error is manually cleared during service there have been no reports of injury as a result of this potential motion.
  • Action
    A Siemens local service engineer will contact customers to perform the inspection and schedule any necessary repairs to the affected systems. Siemens is advising that while waiting for the inspection to be performed, customers can continue to use their systems by adhering to the Cautions and Warnings in the user's manual and observing the patients during studies. This action has been closed-out on 08/08/2016.

Device

Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)
  • Model / Serial
    Symbia S and T Series camera systems (SPECT/CT nuclear medicine diagnostic imaging system)Catalogue numbers: 8717733, 8717741, 10275007, 10275008, 10275009 & 10275010ARTG numbers: 123883 & 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

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