Events

Recall of STERIS 5085 and 5085SRT Surgical Table

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia 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-2014-RN-01185-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01185-1
  • 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 manufacturer, steris corporation, has learned through customer feedback and field service experience that the shroud cover for the hydraulic column may become misaligned and damaged as a result of extreme articulation or excessive pressure on the side or base of the table. in most instances, the shroud damage is minor and does not affect the vertical up/down movement of the hydraulic column. in cases of sever shroud damage, the shroud sections may become misaligned such that vertical movement of the hydraulic column is impeded. no patient injury or adverse health outcomes have been reported due to this issue.
  • Action
    Device Technologies Australia (DTA) representative will contact the customer to arrange an upgrade to correct the problem. DTA is also advising customers that the 5085/5085SRT Surgical Tables can continue to be operated in the interim. This action has been closed-out on 11/08/2016.

Device

STERIS 5085 and 5085SRT Surgical Table
  • Model / Serial
    STERIS 5085 and 5085SRT Surgical Table Product codes: ST-01-410-1, ST-01-460-7, ST-480-7 and ST-01-480-06 Serial Number Range: 0403809001-0425514019ARTG number: 149156
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd