Events

Device Recall Surgical Table Headrest 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
    51994
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1418-2009
  • 사례 시작날짜
    2009-05-08
  • 사례 출판 날짜
    2009-05-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81848
  • 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 for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the vertier surgical table.
  • 조치
    An "URGENT: Device Recall" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.

Device

Device Recall Surgical Table Headrest
  • 모델명 / 제조번호(시리얼번호)
    All surgical tables with headrest, Catalog/Part #0788-300-012. No Lot numbers.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution and Canada.
  • 제품 설명
    Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. || The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.
  • 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