Events

Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Instruments Div. of Stryker Corporation 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
    56652
  • 사례 위험등급
    Class 2
  • 사례 연번
    z-2640-2010
  • 사례 시작날짜
    2010-07-15
  • 사례 출판 날짜
    2010-10-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94182
  • 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
    Instrument, Ultrasonic Surgical - Product Code LFL
  • 원인
    Stryker instruments acquired the sonopet ultrasonic surgical system from mutoh co. ltd on 3/29/2010. stryker determined that the sonopet consode did not meet the iec-60601-1 standard. stryker decided to recall the sonopet consode.
  • 조치
    The firm to send URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to customers dated 7/15/2010. The customers were instructed to continue to use the device. Stryker technicians were dispatched to replace a board with a new board.

Device

Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Wordwide
  • 제품 설명
    Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • 제조사 주소
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA