Events

Device Recall Flexicair II 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom Manufacturing, 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
    57592
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1253-2011
  • 사례 시작날짜
    2010-12-06
  • 사례 출판 날짜
    2011-02-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96736
  • 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, flotation therapy, powered - Product Code IOQ
  • 원인
    Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
  • 조치
    Hill-Rom Manufacturing, Inc. sent an Urgent Medical Device Withdrawal letter dated December 15, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The FLEXICAR MC3 AND FLEXICAIR 13000 were no longer available for rental as of November 15, 2010. Customers in Michigan were required to switch to another product by December 31, 2010. All other customers were required to switch to another product by March 4, 2011. Customers advised to continue the use of the product until arrangements could be made to replace the product. were notified by letter on/about 12/06/2010. The letter indicated the units will no longer be available for rental as of 11/15/2010. Patients in Michigan currently using the products will be required to switch to another product by 12/31/2010. All other patients using the products will be required to switch to another product by 03/04/2010. They were advised that a Hill-Rom representative will be contacted them to discuss details of the product withdrawal and possible alternative surfaces for their patients. For questions regarding this recall call 800-445-3720.

Device

Device Recall Flexicair II
  • 모델명 / 제조번호(시리얼번호)
    All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA
  • 제품 설명
    Flexicair¿ II (Model number 13000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • 제조사 주소
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA