Events

Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Handicare Accessibility 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
    63859
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0171-2014
  • 사례 시작날짜
    2012-11-29
  • 사례 출판 날짜
    2013-11-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114924
  • 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
    Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub.
  • 조치
    Handicare sent an Urgent Medical Device Recall letter dated November 29, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately advise all of their customers affected by the recall letter to immediately remove all affected product from use. Upon receipt of affected product, replacement handsets would be sent to customers. Customers with questions were instructed to call 866-276-5438 or email Customerservice.usa@handicare.com. For questions regarding this recall call 610-266-5260.

Device

Device Recall Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), handset
  • 모델명 / 제조번호(시리얼번호)
    Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (Nationwide) and country of: Canada.
  • 제품 설명
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) || Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing.
  • Manufacturer
    Handicare Accessibility

Manufacturer

Handicare Accessibility
  • 제조사 주소
    Handicare Accessibility, 2201 Hangar Place, #200, Allentown PA 18109
  • 제조사 모회사 (2017)
    Handicare Group Ab
  • Source
    USFDA