Events

Technical Name: CT Scanner ANVISA Registration Number: 80071260079 Hazard Class: III Model Affected: Optima CT 540 Serial Numbers Affected: • BrightSpeed ​​Select (ANVISA 80071260096) • Optima CT 540 ANVISA 80071260079) • Optima CT 580, Discovery RT (ANVISA Registration 80071260129) • Optima CT660, Revolution EVO (ANVISA Registration 80071260119) • Discovery CT590RT (ANVISA Registration 80071260132) • LightSpeed ​​VCT (ANVISA Registration 80071260076) • LightSpeed ​​RT16 (ANVISA Registration 80071260091) • Discovery PET / CT 600, 690 (ANVISA Registration 80071260109) • Discovery PET / CT 610, Discovery PET / CT 710 (ANVISA Registry 80071260295) • Discovery IQ (ANVISA Registration 80071260344); • Discovery MI, Discovery MI DR (ANVISA Registration 80071260295) • Optima PET / CT560 (ANVISA Registration 80071260130) • Discovery NM / CT670, 670 Pro, 670 ES (ANVISA Registration 80071260354) 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 HANGWEI MEDICAL SYSTEMS CO, LTD. 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
    2302
  • 날짜
    2017-05-26
  • 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
    Systems can continue to be used safely. To do so, all users should adhere to the following instructions to avoid the possible occurrence of this problem: 1. Review the "Emergency Devices" section in your user manual. An update to the User's Guide is included in this package. Use the Emergency Stop Button only for patient-related emergencies. 2. If you press the Emergency Stop Button during the preparation period, always finish the current exam and start a new examination, including observation scans, to avoid incorrect timing of preparation time.
  • 원인
    A problem has been identified that can result in the sweep firing before the time required for patient preparation is completed. this problem occurred only once, in clinical use, in a particular situation, in which a very specific set of steps were performed. more specifically, if an examination is interrupted during the patient's preparation period using the emergency stop button and the scan is resumed, the next time interval for the preparation may be less than expected. in this case, if there are personnel present in the examination room, at the time of the start of the premature sweep, they may be exposed to secondary radiation.
  • 조치
    Field Action IMF Code 25474 triggered under the responsibility of GE Healthcare do Brasil, Com. E Serv. for Equipos Médico-Hospitalares Ltda. Company will update, correct or supplement the instructions for use.

Device

Technical Name: CT Scanner ANVISA Registration Number: 80071260079 Hazard Class: III Model Affect...

Manufacturer

GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hospitalares Ltda.; GE HANGWEI MED...