Events

Device Recall SOPRO Camera Control Unit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew, Inc Endoscopy Division 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
    37819
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0781-2007
  • 사례 시작날짜
    2007-01-19
  • 사례 출판 날짜
    2007-05-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-09-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51613
  • 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
    Endoscope camera control unit - Product Code FWF
  • 원인
    Surgical camera control units were not designed and manufactured to pass the iec 60101 testing for electrical fast transients (eft).
  • 조치
    Recalling firm sent Recall notification letters to customers (Jan 2007) and distribution centers requesting device return.

Device

Device Recall SOPRO Camera Control Unit
  • 모델명 / 제조번호(시리얼번호)
    Serial #s: BE, 420-8161, 420-8013, 420-8026, 420-8056, 420-8041, 420-8134, 420-8137, 420-8059, 420-8135, 420-8010, 420-8014, 420-8132, 420-8018, 420-8020, 420-8035, 420-8045, 420-8114, 420-8115, 420-8136, 420-8140, 420-8143, 420-8146, 420-8149, 420-8155, 420-8113, 420-8142, 420-8151, 420-8154, 420-8058, 420-8050, 420-8033, 420-8138, 420-8038, 420-8054, 420-8036, 420-8037, 420-8043, 420-8133, 420-8025, 420-8015, 420-8019, 420-8028, 420-8030, 420-8031, 420-8032, 420-8042, 420-8049, 420-8057, 420-8039, 420-8119, 420-8120, 420-8040, 420-8118, 420-8145, 420-8152, 420-8046, 420-8011, 420-8055, 420-8141, 420-8021, 420-8112, 420-8024, 420-8048, 420-8144, 420-8016, 420-8017, 420-8022, 420-8023, 420-8047, 420-8052, 420-8044, 420-8034, 420-8053, 420-8029, 420-8051, 420-8058.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Foreign Distribution Only-No U. S. A. distribution International distribution to: Argentina, Austria, Australia, Belgium, Brazil, China, Columbia, Denmark, Dubai, France, Germany, Greece, Italy, India, Japan, Korea, Malaysia, Netherlands, Norway, Portugal, South Africa, Spain, Sweden, Turkey and United Kingdom.
  • 제품 설명
    SOPRO Camera Control Units, NTSC, SV420P; REF (Catalog) #72200505 v1.1; Made in France; Manufactured for Smith & Nephew, Inc., Endoscopy, Andover, MA 01810.
  • Manufacturer
    Smith & Nephew, Inc Endoscopy Division

Manufacturer

Smith & Nephew, Inc Endoscopy Division
  • 제조사 주소
    Smith & Nephew, Inc Endoscopy Division, 76 S. Meridian Ave, Oklahoma City OK 73107-6512
  • Source
    USFDA