Model: T2100, Brand: GE Healthcare, Register: 80071260189, T2100 Treadmills that use power cords with the following part numbers :. • 408930-001 REV E - manufactured from June 1, 2006 until December 10, 2014. If the cable has the RWK identification it means that it has already been inspected (SEE CUSTOMER'S CHART) ///. • 408930-002 REV C - manufactured from June 1, 2006 through January 19, 2015. ///. • 2028038-008 REV B - manufactured from December 1, 2006 through January 28, 2015. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE Medical Systems Information Technologies, INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1531
  • 날짜
    2015-02-24
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the registrant, as a consequence of the problem, electrical shock may occur under the three conditions listed below: 1) The power cord has a grounded connection. 2) When there is deterioration or loss of electrical insulation on some internal conductors that may come in contact with the chassis. 3) The patient or operator comes into simultaneous contact with the equipment and a path to the ground. #### Update of the field action: UPDATED ON 10/23/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • 원인
    The power cord attached directly to the t2100 treadmill may not have been mounted in accordance with the instructions resulting in a grounding compromise. the problem may lead to failure of the insulation of the power conductor generating energization of the conveyor chassis.
  • 조치
    The company instructs the user to perform the leakage current tests specified in the T2100 Treadmill Service Manual supplied as part of the product. If the results indicated are acceptable the company clarifies that the chassis is not energized and there is no failure in the test. If results are not acceptable, the user should discontinue use of the equipment and contact GE Technical Support for assistance. The company reinforces the guidance on performing routine maintenance on these equipment.