Events

Leckey 4Point Pelvic Harness Belts 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Patterson Medical Holdings, 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
    52114
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2040-2009
  • 사례 시작날짜
    2009-04-17
  • 사례 출판 날짜
    2009-09-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-05-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82118
  • 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
    Mechanical chair - Product Code INN
  • 원인
    The plastic buckles on the hip belts of the 4-point pelvic harness may break.
  • 조치
    Sammons Preston, the U.S. agent for James Leckey Design Ltd., issued recall letters dated 4/17/09 to all of their customers who purchased the Leckey 4-Point Pelvic Harness, used in the Leckey Contoured Advance Seat, Leckey Early Sitting System and the Leckey Squiggles Saddle Seat, informing them that the manufacturer, James Leckey Design Ltd., is recalling the harness because the pelvic belt buckle may not lock securely and/or break. A copy of the Urgent Field Safety Notice dated 1/28/09 issued by Leckey in the United Kingdom was included with the Sammons letter. The customers were advised to be vigilant and check the hip belts daily to ensure that the user is secure in their seating system until the replacement hip belt is received. The accounts were requested to contact Carla Dreher at 1-800-288-3693, ext. 8724 for instructions on how to receive a replacement hip belt.

Device

Leckey 4Point Pelvic Harness Belts
  • 모델명 / 제조번호(시리얼번호)
    All belts supplied on the affected seating systems between September 2007 and December 2008
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada
  • 제품 설명
    Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: || a) Leckey Contour Advance Seat, Size 1, catalog 081117209; || b) Leckey Contour Advance Seat, Size 2, catalog 081117217; || c) Leckey Squiggles Saddle Seat, catalog 081326941; || d) Leckey Early Sitting System, catalog 081395193
  • Manufacturer
    Patterson Medical Holdings, Inc.

Manufacturer

Patterson Medical Holdings, Inc.
  • 제조사 주소
    Patterson Medical Holdings, Inc., 1000 Remington Blvd Ste 210, Bolingbrook IL 60440-5116
  • Source
    USFDA