Events

Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging systems for intravascular ultrasound and pressure control Volcano s5 and Volcano s5i: device for pulling a single-use catheter Trackback II: 91003 를 위한 리콜 또는 안전성 경고

Ministry of Health of the Republic of Belarus에 따르면, 해당 리콜 또는 안전성 경고 는 Belarus 에서 Volcano Corporation, USA 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
    Recall / Safety alert
  • 사례 연번
    ИМ-7.99871
  • 날짜
    2014-01-10
  • 사례 국가
    Belarus
  • 사례 출처
    MHRB
  • 사례 출처 URL
    https://www.rceth.by/ru/Safety/MedSafety
  • 비고 / 경고
    Belarussian data is current through June 2016. All of the data comes from Health Canada, 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 Belarus.
  • 데이터 추가 비고
  • 원인
    Volcano corporation has initiated a voluntary recall of all lots of the device for pulling a single-use catheter trackback ii: code 91003. the trackback ii is intended for use with eagle eye® intravascular imaging catheters. the device provides stable and accurate movement of the catheter, which allows you to evenly collect image data. the recall is initiated by the company as a precautionary measure due to concerns about the integrity of the primary packaging, which may affect the sterility of the product after shipment. volcano corporation has not received any complaints about this and no reports of harm to the patient or his death caused by the use of the product. however, the company asks to immediately stop using the device in trackback ii and return unused devices to the distributor.

Device

Ultrasound intravascular Volcano systems with accessories: catheters and accessories for imaging ...

Manufacturer

Volcano Corporation, USA
  • 제조사 모회사 (2017)
    Philips
  • Source
    MHRB