Events

Device Recall LIFEPAK 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Physio Control Corp 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
    27864
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0294-04
  • 사례 시작날짜
    2003-11-12
  • 사례 출판 날짜
    2004-01-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-02-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30656
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • 데이터 추가 비고
    unknown device name - Product Code MKI
  • 원인
    Device unable to recognize the connection to the hard paddles accessory.
  • 조치
    Beginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.

Device

Device Recall LIFEPAK
  • 모델명 / 제조번호(시리얼번호)
    Part numbers: 3200936-000, 3200936-001, 3200936-003, 3200936-010.   Date codes affected: 19680, 19681, or 19682  The firm shipped sets of paddles with shipments of devices with serial numbers listed. However, a set of paddles was not shipped specifically with each LP 20, and a customer may receive (per order) more devices than paddle sets. The paddles may be used with the devices specified below, or with any other LP 20 device. LP 20 serial numbers shipped: 31481310, 31487712, 31469046, 31480240, 31488466, 31488468, 31488472, 31488479, 31488482, 31488483, 31488485, 31488486, 31488487, 31488491, 31488492, 31488494, 31488495, 31488498, 31488499, 31488500, 31488502, 31488503, 31488505, 31488970, 31488971, 31488976, 31490835, 31490862, 31490864, 31490865, 31490914, 31492668, 31494830, 31494961, 31495055, 31496204, 31496499, 31496500, 31496502, 31497170, 31497171, 31497173, 30540237, 30541490, 30524326, 31405298, 31405302, 31406327, 31406328, 31406329, 31406330, 31407066, 31420549, 31461553, 31461548, 31461559, 31461565, 31451566, 31461568, 31461569, 31461575, 31461576, 31461578, 31461580, 31461583, 31469733, 31469741, 31469747, 31481173, 31481174, 31481261, 31481265, 31481277, 31481279, 31481281, 31490863, 31490913, 31491385, 31491387, 31491390, 31491441, 31491443, 31491445, 31491384, 31491388, 31491442, 31461579, 31491444, 31494875, 31494878, 31494883, 31494884, 31490836, 31492587, 31480230, 31488975, 31494882, 31488501, 31481264, 31409217, 31481262, 31412444, 31488474, 31488470, 31481152, 31481183, 31486080, 31486083, 31488340, 31488343, 31488344, 31495057, 31495686, 31499486, 31481318, 31488973, 31491581, 31469686, 31462754, 31461567, 31461555, 31461564, 31471398, 31462757, 31461558, 31469688, 31492591, 31461574, 31480226, 31462758, 31487665, 31469037, 31469038, 31469039, 31469041, 31469043, 31469044, 31469045, 31469689, 31469690, 31480222, 31480232, 31480234, 31480238, 31469678, 31469719, 31469707, 31469727, 31461560, 31481193, 31486082, 31487666, 31461570, 31469675, 31469677, 31469680, 31469682, 31469704, 31469709, 31469714, 31481269, 31491801, 31492056, 31492128, 31469711, 31469699, 31494874, 31461551, 31493149, 31471394, 31493147, 31480235, 31461577, 31462761, 31462768, 31469670, 31481321, 31488341, 31488342, 31488481, 31488489, 31488490, 31488493, 31488497, 31488504, 31488977, 31491065, 31491580, 31491803, 31492053, 31492588, 31492589, 31492590, 31492667, 31492669, 31493144, 31493146, 31493148, 31494428, 31494430, 31494433, 31494434, 31495056, 31495058, 31495059, 31495409, 31496498, 31501828, 31501829, 31469702, 31448168, 31461573, 31469710, 31469661, 31469684, 31496197, 31481313, 31469726, 31469730, 31462762
  • 의료기기 분류등급
    Cardiovascular Devices
  • 유통
    The firm distributed devices to 32 hospitals and medical centers located throughout the United States.
  • 제품 설명
    LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.
  • Manufacturer
    Medtronic Physio Control Corp

Manufacturer

Medtronic Physio Control Corp
  • 제조사 주소
    Medtronic Physio Control Corp, 11811 Willows Rd NE, Redmond WA 98073
  • Source
    USFDA