EasyCare 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Joerns Healthcare 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
    69400
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0151-2015
  • 사례 출판 날짜
    2014-10-30
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, ac-powered adjustable hospital - Product Code FNL
  • 원인
    The easy-care care-lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the care-lock system has been engaged by stepping on the red (locked) pedal.
  • 조치
    Joerns sent an Urgent: Medical Device Correction letter dated September 24, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm will provide the customers with a temporary solution kit to safegard the bed until a replacement Care-Lock assembly can be shipped and installed. Customers were instructed to complete the response form. For questions call 800-826-0270.

Device

  • 모델명 / 제조번호(시리얼번호)
    901172875, 901173369-901173393, 901173395, 901173417, 901173422-901173423, 901173443-901173447, 901173558-901173560, 901173762-901173776, 901173854-901173857, 901173860-901173861, 901173914, 901174007-901174013, 901174014-901174015, 901174027-901174029, 901174031, 901174033-901174058, 901174162, 901174251-901174302, 901174319-901174320, 901174323, 901174331, 901174342-901174385, 901174389, 901174412-901174426, 901174429-901174430, 901174491-901174521, 901174531-901174541, 901174710-901174716, 901174845, 901174850-901174892, 901174895-901174896, 901174898-901174899, 901174980-901175087, 901175089-901175095, 901175098-901175117, 901175120, 901175123-901175130, 901175185-901175196, 901175202-901175217, 901175225-901175229, 901175246-901175249, 901175341-901175347, 901175359-901175378, 901175380-901175381, 901175383-901175385, 901175387-901175388, 901175392-901175501, 901175513-901175514, 901175533-901175543, 901175549-901175550, 901175553-901175555, 901175571-901175646, 901175688-901175717, 901175719-901175740, 901175745-901175768, 901175792-901175827, 901175988-901175998, 901176002-901176006, 901176008-901176014, 901176033-901176056, 901176059-901176060, 901176065-901176185, 901176187-901176188, 901176190-901176205, 901176223-901176226, 901176230, 901176243-901176254, 901176265-901176281, 901176292-901176311, 901176314-901176316, 901176318-901176323, 901176326-901176331, 901176333-901176340, 901176343, 901176352-901176362, 901176365-901176366, 901176370-901176371, 901176374-901176379, 901176383-901176387, 901176397-901176401, 901176419-901176420, 901176431-901176440, 901176451-901176463, 901176493, 901176495-901176505, 901176513-901176585, 901176644-901176772, 901176317, 901780437-901780453, 901780458-901780460, 901780462-901780574, 901780596-901780722, 901780726-901780735, 901780738-901780744, 901780746-901780756, 901780874-901780910, 901781000-901781435, 901781556-901781570, 901781577-901781610, 901781616-901781625, 901781634-901781684, 901781688-901781726, 901781732-901781733, 901781751-901781766, 901781780-901781875, 901781877, 901781886-901781887, 901781889-901781892, 901781919-901781920, 901781928-901782000, 901782023-901782035, 901782037-901782120, 901782122-901782130, 901782135, 901782157-901782160, 901782172, 901782178-901782192, 901782214-901782218, 901782229-901782233, 901782241-901782249, 901782275-901782283, 901782290-901782291, 901782354-901782364, 901782376-901782383, 901782385-901782387, 901782390-901782414, 901782417-901782428, 901782430, 901782432-901782433, 901782558-901782559, 901782577-901782579, 901782582-901782591, 901782594-901782608, 901782619-901782620, 901782622-901782624, 901782635-901782636, 901782639-901782653, 901782661-901782726, 901782728-901782746, 901782749-901782776, 901782778-901782795, 901782801-901782802, 901782805-901782806, 901782841-901782889, 901782893-901782906, 901782910-901782941, 901782982-901782988, 901782992-901782993, 901782999-901783004, 901783027, 901783121-901783125, 901783130-901783142, 901783144-901783145, 901783158-901783170, 901783172-901783179, 901783194-901783201, 901783233-901783246, 901783318-901783332, 901783337-901783342, 901783345-901783351, 901783358-901783362, 901783364-901783374, 901783392-901783395, 901783398-901783400, 901783408, 901783416-901783418, 901783423-901783429, 901783431, 901783434
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • 제품 설명
    Joerns EasyCare Bed || Product Usage: || The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA