Events

Device Recall 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
    48197
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2189-2008
  • 사례 시작날짜
    2008-05-01
  • 사례 출판 날짜
    2008-09-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-01-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70986
  • 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
    Table, Operating-Room, Ac-powered - Product Code FQO
  • 원인
    Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on vertier surgical table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
  • 조치
    Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance. Contact Karen Smith-Mosley at 972-410-7310 if you have questions.

Device

Device Recall Surgical Table
  • 모델명 / 제조번호(시리얼번호)
    Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; and 071019-38649.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to the following states: CA, CO, TX and UT.
  • 제품 설명
    Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.
  • 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