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

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 In Vitro Technologies Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-00248-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-15
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    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.
  • 데이터 추가 비고
  • 원인
    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.
  • 조치
    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

  • 모델명 / 제조번호(시리얼번호)
    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

Manufacturer