Events

Base array component of the MAKO RIO Robotic Arm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-2015-RN-00873-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-09-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00873-1
  • 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 base array and the base array connector is a two piece component on the rio that is used by the rio camera to determine location of the rio relative to the patient. the pin which olds the base array in position and prevents movement has been visually confirmed to have been damaged during assembly.Incidences have been reported where the locking pin on the rio base array may be damaged during assembly onto the rio base array connector.The incidence of this issue is uncommon (only 0.15% of cases over the past 36 months) and, of the reported cases, all were successfully completed with no reported injury to the patient or operating room staff.
  • 조치
    Users are requested to complete and return the notification response. A Stryker Representative will be in contact and a new RIO Base Array Connector and Base Array will be installed on the RIO system during regularly scheduled product maintenance. A workaround is also provided for interim use of the system.

Device

Base array component of the MAKO RIO Robotic Arm
  • 모델명 / 제조번호(시리얼번호)
    Base array component of the MAKO RIO Robotic ArmCatalogue Numbers:207300 (207956) MAKO RIO Robotic Arm112220 RIO Base Array205143 RIO Base Array ConnectorLot/Serial Numbers: AllARTG Number: 223105
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA