Events

ECATS 2000 Safety Net Enclosure Medical Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Extended Care Air Therapy Systems Inc 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
    36125
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0026-2007
  • 사례 시작날짜
    2006-04-05
  • 사례 출판 날짜
    2006-10-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48047
  • 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 - Product Code FNL
  • 원인
    Component defect- following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall.
  • 조치
    The firm sent a Product Advisory Letter to their distributor/customers on 4/5/2006. The letter instructs the distributors as to the correct way to handle the beds during movement, loading, and unloading onto delivery trucks. The letter also urges the distributors to inspect the bed frame units in inventory at their locations for the presence of any bending, or damage to the four frame bolts. The letter states that the company will replace the bolts as soon as possible when ever necessary.

Device

ECATS 2000 Safety Net Enclosure Medical Bed
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: E9084 - E9094 & E10001 - E10099. The serial # is found at the bottom of the stick on label. The label is affixed to the foot of the bed frame on the right hand side.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled medical beds were distributed to six (6) wholesale/distributor customers located in the following states: KS, TN, MI, PA, and LA.
  • 제품 설명
    ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
  • Manufacturer
    Extended Care Air Therapy Systems Inc

Manufacturer

Extended Care Air Therapy Systems Inc
  • 제조사 주소
    Extended Care Air Therapy Systems Inc, 7165 Payne Rd, Roseville OH 43777-9711
  • Source
    USFDA