Events

Laser photocoagulator Easyret software version 1.03 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies Australia 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-00507-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-04-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00507-1
  • 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
    The manufacturer quantel medical has become aware of an issue with the micropulse mode of the easyret laser (qm-pabx0017, serial number 155) in software version 1.03. if the validation key of the intermediate window for treatment lens and spot size selection is pressed twice when selecting the micropulse mode, a software bug leading to the delivery of an erroneous level of energy corresponding to a 100% duty cycle when in treatment session will be created. this issue could cause photocoagulation of the retina in patients.
  • 조치
    Device Technologies Australia (DTA) is advising users to discontinue use of the MicroPulse mode on the device until the software update in version 1.04 has been completed by a DTA representative. This action has been closed-out on 15/03/2018.

Device

Laser photocoagulator Easyret software version 1.03
  • 모델명 / 제조번호(시리얼번호)
    Laser photocoagulator Easyret software version 1.03Product Code: QM-PABX0017Serial Number: 155ARTG Number: 130657
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd