Device Recall Eye Surgery Stryker Medical Stretchers Model 1089 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Medical Division 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
    59201
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2864-2011
  • 사례 시작날짜
    2011-07-19
  • 사례 출판 날짜
    2011-07-22
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2013-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Stretcher, Wheeled - Product Code FPO
  • 원인
    The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa.
  • 조치
    Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
  • 제품 설명
    Eye Surgery Stryker Medical Stretchers Model 1089 || Intended to transport patients in a horizontal position.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • 제조사 모회사 (2017)
  • Source
    USFDA