Events

Device Recall Stryker Medical S3 MedSurg 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
    73255
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2353-2016
  • 사례 시작날짜
    2016-02-02
  • 사례 출판 날짜
    2016-08-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143629
  • 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
    Cpu board failures cause fowler (backrest) electronic controls to stop working.
  • 조치
    Stryker Medical initiated a voluntary recall of the S3 MedSurg Bed, Model 3005, with notices sent on February 2, 2016 via certified mail. Stryker medical identified that Fowler does not raise up to desired angle; and the Fowler does not raise electronically, but manual function remains operational through the manual CPR release. Actions Needed for Customers: 1. Locate the bed(s) listed by serial number on the attached business reply form. 2. A Stryker ProCare Representative will contact your facility to schedule a time for repair. 3. Fax (269)488-8691 or email productfieldaction@stryker.com the enclosed business reply form to confirm receipt of this notification. 4. If you have further distributed the beds listed in this letter, please forward a copy of this notice to the new users and advise us of their new location. If you have any urgent questions or concerns, please, contact Stryker Customer Service at (1-800-327-0770). Normal business hours are Monday-Friday 8 a.m-5 p.m. (ET).

Device

Device Recall Stryker Medical S3 MedSurg Bed

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