Events

Recall of E.CAM or Symbia E System: Rear Casters of the Collimator Cart

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-00855-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00855-1
  • 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
    The rear casters of the collimator cart may become loose and under certain circumstances result in the cart tipping towards the operator. this problem occurs when two conditions are present: 1. the caster has insufficient clamping force and 2. the affected caster passes over a low spot in the floor. if both conditions exist, it is possible the caster will dislodge from the bottom of the cart, allowing the cart to tip backwards toward the operator.
  • Action
    End users are advised that they can continue to use your system while waiting for the field correction to be scheduled and performed. However, if you suspect a caster is loose, as indicated by shaking while the cart is in motion, discontinue use of the collimator cart and notify your local Service representative. A retention bracket will be installed on all affected devices to correct the problem. This action has been closed-out on 24/05/2016.

Device

E.CAM or Symbia E System: Rear Casters of the Collimator Cart
  • Model / Serial
    E.CAM or Symbia E System: Rear Casters of the Collimator CartCatalogue numbers: Collimator Carts 7760908, 7760882ARTG number: 186317
  • Manufacturer
    Siemens Ltd

Manufacturer

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