Events

Device Recall VISU 200 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carl Zeiss Meditec Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52716
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0904-2011
  • 사례 시작날짜
    2009-05-18
  • 사례 출판 날짜
    2011-01-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83806
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Microscope, surgical - Product Code EPT
  • 원인
    Potential retina damage-- an error in the user manual may result in misapplied filter and injury during treatment.
  • 조치
    Carl Zeiss Meditec Inc sent a SAFETY ALERT letter dated May 18, 2009, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were reminded to use the correct retinal protection filter (GG475) when using the OPMI VISU 200 system during ophthalmic surgery. Verify the position of the retinal protection filter and inform their staff of the customizable feature. Verify that the correct filter was in place. Customers were asked to complete the acknowledgement form indicating receipt of the alert. Sign and return the form to: Carl Zeiss Meditec in Dublin, California via the enclosed self-addressed, pre-paid Federal Express envelope. For any questions customers should call (925) 557-4422.

Device

Device Recall VISU 200
  • 모델명 / 제조번호(시리얼번호)
    User manuals with numbers G-30-1246-e, G-30-1284-e, G-30-1284-en, and G-30-1236-en, affecting all stands.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution including USA (nationwide) and the UK
  • 제품 설명
    VISU 200 on S8 Floor Stand, Manufactured by Carl Zeiss Surgical GmbH, Germany || Medical device: Surgical microscope used during ophthalmic surgeries, which allows real time visualization of the surgical area. || Product Quantity Distributed (Int) 2540 units
  • Manufacturer
    Carl Zeiss Meditec Inc

Manufacturer

Carl Zeiss Meditec Inc
  • 제조사 주소
    Carl Zeiss Meditec Inc, 5160 Hacienda Dr, Dublin CA 94568
  • 제조사 모회사 (2017)
    Carl-Zeiss-Stiftung
  • Source
    USFDA