Events

Recall of Siemens e.cam Systems (Nuclear medicine gamma camera)

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-2015-RN-00657-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00657-1
  • 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 a report of unintended detector motion. the cause of this motion was determined to be the simultaneous failure of two components, the radial brake circuit and touch pad. this unique combination of failures caused the axis brake to be ineffective, which ultimately led to the detector motion. additionally, activating the emergency stop (e-stop) or a system power failure, between 0.05 and 0.1 seconds after initiating motion could lead to this failure. siemens has determined that the likelihood that these events would occur over such a small time window is extremely rare. the most likely condition that could lead to a rapid power cycling is a touch pad failure. there have been no reports of injury as a result of this issue; however, it is remotely possible that a compression injury to the patient could occur.
  • Action
    -PRODUCT CORRECTION Siemens has designed and will install an improved brake control circuit which will correct this condition. Users are advised that the e-stop should still be used confidently and they can continue to use their system with confidence while waiting for the repair to be scheduled and performed. Users are reminded that daily touch test and/or its failure should not be ignored. If they experience difficulty or a failure while performing the daily touch pad test, discontinue use and contact their local service representative. This action has been closed-out on 05/09/2016.

Device

Siemens e.cam Systems (Nuclear medicine gamma camera)
  • Model / Serial
    Siemens e.cam Systems (Nuclear medicine gamma camera) Multiple catalogue numbers installed prior to December 31st 2004 affectedPart numbers: 4380213, 4380221, 5242826, 5977066, 5989079, 5991109, 5992099, 7324143, 7823946, 7823953. ARTG number: 186317
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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