Events

Device Recall Point Scanning Confocal Microscope TCS SP5/TCS SP5 X 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Leica Microsystems, 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
    54165
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1221-2010
  • 사례 시작날짜
    2009-11-12
  • 사례 출판 날짜
    2010-05-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-05-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87748
  • 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
    Spectroscopy Instrument - Product Code REM
  • 원인
    A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.
  • 조치
    A Service Note was sent to service organizations on November 12, 2009. The communication asked customers to check if they must exchange their shutters and send their planned exchange date by 2009-11-20 to clsm.qc@leica-microsystems.com. Customers were also asked to check the serial numbers of the one-wire chips of the shutters. Then lastly, the were asked to exchange the shutters and confirm the exchange.

Device

Device Recall Point Scanning Confocal Microscope TCS SP5/TCS SP5 X
  • 모델명 / 제조번호(시리얼번호)
    Shutter HX SP5, Material No: 1531160006 Spare Part No: 15000904000093
  • 의료기기 등급
    Not Classified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain.
  • 제품 설명
    Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. || Laboratory instrument.
  • Manufacturer
    Leica Microsystems, Inc.

Manufacturer

Leica Microsystems, Inc.
  • 제조사 주소
    Leica Microsystems, Inc., 2345 Waukegan Rd, Bannockburn IL 60015-1515
  • Source
    USFDA