Events

Device Recall McKesson SunMark Performance Wheelchair, 18" Seat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cypress Medical Products, Ltd. 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
    31147
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0642-05
  • 사례 시작날짜
    2004-05-03
  • 사례 출판 날짜
    2005-03-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-08-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37288
  • 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
    Wheelchair, Mechanical - Product Code IOR
  • 원인
    The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
  • 조치
    Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.

Device

Device Recall McKesson SunMark Performance Wheelchair, 18" Seat
  • 모델명 / 제조번호(시리얼번호)
    reorder no. 16-7901, 16-7902, 16-7903, 16-7904, 16-7905, 16-7906, all serial numbers
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA
  • 제품 설명
    Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: || reorder 16-7901: Fixed Full Arm, Fixed Footrest || reorder 16-7902: Fixed Full Arm, Swing Footrest || reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest || reorder 16-7904: Removable Desk Arm, Swing Footrest || reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrest || reorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest
  • Manufacturer
    Cypress Medical Products, Ltd.

Manufacturer

Cypress Medical Products, Ltd.
  • 제조사 주소
    Cypress Medical Products, Ltd., 1202 S. Rte 31, McHenry IL 60050
  • Source
    USFDA