Events

STERRAD NX, Model Plasma Sterilization System Hydrogen Peroxide Sterrad - Registration 10132590628. Product Code 10033, SNs: 0033130118; 0033130544; 0033140005; 0033140026; 0033140012; 0033130288; 0033140050; 0033130424; 0033131009; 0033140011; 0033130276; 0033140021; 0033140040; 0033130441; 0033130250; 0033130277 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda 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
    1704
  • 날짜
    2015-10-27
  • 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
    The company informs that the STERRAD® NX® Sterilization System may interfere with other electronic equipment used by operators and / or implantable devices used in close proximity to the STERRAD® NX® Sterilization System. Based on our analysis, the risk of interference is low for the active deployment and use devices and other nearby electrical equipment.
  • 원인
    Asp has recently identified that a sterrad® nx® sterilization system may exceed the international standard's radiated emission limit by 20 decibels microvolts per meter (db v / m), which is equivalent to 0.001 volts per meter (v / m) at a distance of 10 meters.
  • 조치
    The STERRAD® NX® Sterilization System User Guide (M-99920_07), Chapter 2 - "Safety Information" contains a chapter titled "Guidelines and Declaration - Electromagnetic Emissions", which provides information on emissions testing and guidance on electromagnetic environment, including reporting compliance with CISPR 11, Group 1 and Class A radio frequency (RF) emissions, which is a subset of the IEC-60601-1-2 Medical Electromagnetic Compatibility (EMC) Standards. ASP has identified that the STERRAD® NX® Sterilization System does not meet the limit of the International Standard for Emissions. ASP advises you to continue to take the usual precautions because of the proximity of the STERRAD® NX® Sterilization System with other electromechanical equipment and electronic medical devices at your facility. You should ensure that everyone at your facility who is affected by this notice reads this letter and follows the risk management procedures in the event of use of any affected product. A copy of this communication must be kept with the affected STERRAD® NX® Sterilization System and complete and return the Business Response Form. Further information: Annex II - Alert message.

Device

STERRAD NX, Model Plasma Sterilization System Hydrogen Peroxide Sterrad - Registration 1013259062...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda