Events

Device Recall InTouch Critical Care Bed 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
    68470
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2122-2014
  • 사례 시작날짜
    2014-06-04
  • 사례 출판 날짜
    2014-07-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127981
  • 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
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 원인
    Stryker has received complaints from the field alleging instances where the in touch beds are hoisted or lifted from the floor and the casters have fallen off. the investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. if more than one caster on a unit is damaged, brake functions can be affec.
  • 조치
    On 06/30/1014 the firm sent "Urgent Medical Device Notification" letters to their customers.

Device

Device Recall InTouch Critical Care Bed
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV, and the countries of Argentina, Brazil, Canada, Chile, China, EMEA, Greece, Italy, Japan, Korea, Latin America, Mexico, Poland, Singapore, South Africa, Taiwan, and UK.
  • 제품 설명
    InTouch Critical Care Bed, Stryker Medical. Model Numbers 2130, 2131, 2140, 2141, 2151, 2152, 2155, and 2156.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • 제조사 주소
    Stryker Medical Division of Stryker Corporation, 3800 E Centre Ave, Portage MI 49002-5826
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA