Events

Device Recall Faaborg Person Lift, VL Series 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Moving Solutions, 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
    28199
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0552-04
  • 사례 시작날짜
    2004-01-21
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-10-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31387
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • 원인
    Excessive wear of the hanger bar bolt, that connects the lift arm to the sling spreader bar, may cause the bolt to snap allowing the patient to fall.
  • 조치
    Letters were sent to all Faaborg lift customers on 11/29/01 and 01/24/04 advising the users that all bolts in connection with the hanger bar must be inspected, greased and tightened, and all defective or worn down bolts and washers must be changed. The 1/24/04 letters included an upgraded maintenance schedule and an Important Service/Safety Reminder, as well as a supply of hanger bar bolt washers. Any questions were directed to Moving Solutions' Service Department at 800-228-7980. Follow-up letters were sent to the accounts on 3/11/04, referencing the 1/21/04 letter and instructing the accounts not to use the lifts until the bolts have been inspected and retrofitted with the washers. Copies of the revised maintenance schedule and operating instructions were included.

Device

Device Recall Faaborg Person Lift, VL Series
  • 모델명 / 제조번호(시리얼번호)
    all VL series models, all serial numbers
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide to nursing homes, residential schools and home patients, and internationally to Canada.
  • 제품 설명
    Faaborg patient lift/hoist, battery operated lifts. The VL series lifts have electric V-shape base widening, with a weight capacity of 365 lbs. to 550 lbs. depending on the base model. Please note: the Faaborg Person Lift arm assembly can be interchanged on the various lift series bases. The arm assembly is labeled ''Faaborgliften Made in Denmark'', while the base plate reads in part ''Faaborg Rehab Technic Lift Model: VL-***** Serial No: **** Capacity: *** KG. Manufactured: **-**** 5600 Faaborg Phone+4570205553 Fax+4570205554'' A sticker is also present on the base reading ''Moving Solutions 800-228-7980 Fax 630-963-9588''. The Users Guide refers to the lift as a ''Faaborghoist''.
  • Manufacturer
    Moving Solutions, Inc.

Manufacturer

Moving Solutions, Inc.
  • 제조사 주소
    Moving Solutions, Inc., 2550 Wisconsin Ave, Downers Grove IL 60515
  • Source
    USFDA