Events

Recall of ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Karl Storz Endoscopy 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-2016-RN-00200-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00200-1
  • 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
    A manufacturing defect has been detected which could lead to the loosening of the rivets of the interface plate that connects the monitor and touch screen to the articulating arms on the trolley (vesa 75/ 100 adaptation with rotation). the riveting of the rotation may not have been carried out according to the manufacturer's specifications.In rare cases, it can lead to a loosening of the connection plate and result in injuries to patients and/or users.
  • Action
    KARL STORZ is advising customers that they can opt for their own engineers to replace the adaptor plates or nominate KARL STORZ to replace the affected component on site.

Device

ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)
  • Model / Serial
    ITD VESA 75/100 Adaptation with Rotation (Articulating Arm on Endoscope Trolley)Lot Numbers: HA.2200.902 and HA.2237.902Multiple Serial Numbers affectedManufactured between 1 June - 26 November 2015.ARTG Number: 168578
  • Manufacturer
    Karl Storz Endoscopy Australia Pty Ltd

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd