Events

Device Recall VERTIER Surgical Table 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Communications Corp 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
    49021
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2377-2008
  • 사례 시작날짜
    2008-07-02
  • 사례 출판 날짜
    2008-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72534
  • 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
    Operating-Room Table - Product Code FQO
  • 원인
    Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
  • 조치
    Urgent: Device Recall letters were sent to consignees on 07/02/08 via FedEx with return receipt. Consignees were asked to discontinue use of the tables until a Stryker representative has come to the facility and updated the table. The firm has identified and validated replacement parts that prevent this occurrence.

Device

Device Recall VERTIER Surgical Table
  • 모델명 / 제조번호(시리얼번호)
    All lot codes/serial numbers.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution --- including states of AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC.
  • 제품 설명
    VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); distributed by Stryker Communications, Flower Mound, TX. || Is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • 제조사 주소
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA