Events

Recall of Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner and disinfectors)

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-2017-RN-00248-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00248-1
  • 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
    This action is further to the one in july 2016 (tga ref.: rc-2016-rn-00909-1) that was for all steelco washers with auto load/unload module. this issue relates to ds1000 washers, which need another s/w update. 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 & send a command for the unloading arm to return to its home state position. if this sensor is somehow inadvertently obstructed/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. this situation could cause an unwanted movement of the unloader arm, causing it to come into contact with the washer’s glass door & potentially causing it to break.
  • Action
    In Vitro Technologies will be organising the installation of a software upgrade on the PLC of all DS1000 washers installed with unloaders. This software change will eliminate the incorrect closure of the machine door due to unintended obstruction of the optical sensors or external parts placed on the table.

Device

Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner an...
  • Model / Serial
    Steelco DS1000 Washer Disinfectors with an auto load/unload module attached(Instrument cleaner and disinfectors)Model Number: DS1000 1SCatalogue Numbers: STCDS10001S_STEAM, STCDS10001S_MIXED, STCDS10001SR_STEAMModel Number: DS1000 2SCatalogue Number: STCDS10002S_MIXEDModel Number: DS1000 3SCatalogue Numbers: STCDS10003S, STC9930030; STCDS10003S_MIXED, STCDS10003S_STEAM ARTG Number: 206635
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd