Events

Recall of Steelco Washer Disinfectors (Instrument cleaner and disinfectors) All Steelco washers with an auto load/unload module attached

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by In Vitro Technologies 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-00909-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00909-1
  • 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
    In regular operation, the photo optical sensor at the end of an unloading table would signal that a rack had reached the endpoint of its travel out of a washer chamber and send a command for the unloading arm to return to its home state position. if this sensor is somehow inadvertently obstructed or disturbed during the unloading process of the rack it has the potential to send a message to the invertor communicating with the plc that it hadn’t fully unloaded the rack. the system is not able to process the fact that it is unloading a rack at the same time the sensor is telling it that the rack had already been unloaded. in this situation it could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door and potentially causing it to break.
  • Action
    In Vitro Technologies will be organising the installation of a software upgrade on all loading and unloading modules. The software change will prevent the system faulting due to unintended obstruction of the unloader sensors.

Device

Steelco Washer Disinfectors (Instrument cleaner and disinfectors) All Steelco washers with an aut...
  • Model / Serial
    Steelco Washer Disinfectors (Instrument cleaner and disinfectors)All Steelco washers with an auto load/unload module attachedCatalogue Numbers: STC9935022, STC99911173, STC9991133, STC9995007, STCC210, STCC211, STCC228ARTG Number: 206635
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd