Events

Device Recall Penner 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Penner Mfg 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
    70151
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1306-2015
  • 사례 시작날짜
    2015-01-30
  • 사례 출판 날짜
    2015-03-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132324
  • 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
    Cover, barrier, protective - Product Code MMP
  • 원인
    If the patient sits on either wing, not squarely on the center section of the stretcher lift, tipping and injury to the operator or patient could result. the device manual was updated with an additional warning statement.
  • 조치
    Beginning on 1/30/2015, the recalling firm sent letters via certified mail to their customers informing them of the change to the stretcher manual along with a revised manual which incorporated those changes. For questions regarding this recall call 402-694-5003.

Device

Device Recall Penner
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311, 04040581312, 04040581313, 04040581314, 04040586101, 04050810401, 04050810402, 04050810403, 04050810404, 04050810406, 04050810408, 04050810410, 04061028101, 04061028102, 04061028103, 04061028104, 04061028105, 04081009901, 04091187201, 04111563801, 04111568501, 05071272201, 05071272202, 05071272203, 05071272204, 05071272205, 05081019501, 05091197901, 05091197902, 05091201301, 05111513201, 05111576501, 05121762001, 06050840801, 06050840802, 06050840803, 06050840804, 06050840805, 06050840806, 06081037501, 06081039402, 06081039403, 06101394201, 07071320201, 07071320202, 07071328501, 07071328502, 07071328503, 07091223901, 07091223902, 07101410901, 07101415901, 08040660501, 08040660502, 08061090801, 08061090802, 08061090803, 08061090804, 08101430502, 08101439601, 09081073301, 09081074401, 09081076501, 09101453401, 09101457101, 09111641101, 09111641301, 10061121201, 10061121202, 10061121203, 10061121204, 10071396601, 10071396602, 10071396603, 10071396604, 10101463201, 10101464701, 10111652001, 11040710501, 11040710502, 11040710503, 11040710504, 11040710505, 11040710506, 11040710507, 11040710508, 11040710601, 11040710602, 11040710603, 11040710604, 11040710605, 11040710606, 11040710607, 11040710608, 11081101401, 11081105901, 11081113501, 11091285601, 11091285602, 11101475201, 11101476201, 11101476401, 11101477901, 11101478101, 12101495201, 12111677201, 12111686301, 12111686302, 12111688401, 03121734201S, 04040581301A
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada.
  • 제품 설명
    Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 || The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.
  • Manufacturer
    Penner Mfg Inc

Manufacturer

Penner Mfg Inc
  • 제조사 주소
    Penner Mfg Inc, 102 Grant St Ste A, Aurora NE 68818-3200
  • Source
    USFDA