Events

Trade name: Ultrasound Equipment for EPIQ Diagnosis; ANVISA registration number: 10216710275; Risk class: II; Model Affected: EPIQ 5; Serial numbers affected: US814C0626; US814C0627; US914C0017; US914C0261; USO14C0601; USO14C0603; USO14C0602; USO14C0604; USO14C0605; USO14C0606; US215C0175; US215C0431; US215C0434; US215C0432; US215C0433; US215C0430; US315C0757; US315C0758; US315C0759; US315C0751; US315C0752; US315C0755; US315C0754; US315C0753; US315C0954; US415C0448; US515C0689 (SCHEDULE OF DISTRIBUTION IN ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda.; Philips Ultrasound, 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
    1900
  • 날짜
    2016-04-17
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    Philips will contact all EPIQ customers to provide replacement service for the connection bolts from the control panel frame to the system by means of bolts less likely to come loose with repeated handling. This service will be provided free of charge. Should you require any additional information or support regarding this issue, please contact our Solution Center at 0800-701-7789. Attendance from Monday to Saturday from 07h to 19h. ### UPDATE on 06/30/2017, the Action was finalized by the company according to the completion report sent.
  • 원인
    The control panel structure of the philips epiq ultrasound system can come loose, with the possibility of this structure detaching from the system. philips will contact you to make the necessary repairs to your system. (letter to the clients in annex).
  • 조치
    Field Correction by replacing the connection bolts of the control panel frame to the system by bolts less likely to come loose with repeated handling; Field action code: FCO79500381; Recommendations to Users and Patients: If, at any time, the control panel structure of your ultrasound system oscillates or appears to be loose, immediately stop using your system and contact your local Philips representative or the Solution Center Philips at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. Otherwise, you can continue using your system.

Device

Trade name: Ultrasound Equipment for EPIQ Diagnosis; ANVISA registration number: 10216710275; Ris...

Manufacturer

Philips Medical Systems Ltda.; Philips Ultrasound, Inc.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA