Events

Device Recall DatexOhmeda 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Datex-Ohmeda 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
    26765
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0937-03
  • 사례 시작날짜
    2003-07-15
  • 사례 출판 날짜
    2003-08-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-11-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28387
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • 원인
    Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
  • 조치
    Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.

Device

Device Recall DatexOhmeda
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers: 40022312, 40022313, 40027688, 40032184, 40032233, 4002321, 40032330, 40032546, 40036365, 40043483, 40043493 through 40043495, 40043497, 40054495, 40065046, 40065073, 40065818, 40067311, 40067345, 40080026, 40080031, 40080032, 40080035 through 40080037, 40080039, 40080041, 40080042, 40080056, 40080063, 40080064, 40080070, 40080073, 40082935, 40082937 through 40082941, 40082975, 40082979, 40082980, 40082981, 40082986 through 40082989, 40083005, 40083008 through 40083028, 40084505, 40084508, 40084509, 40084512, 40084523, 40084524, 40084535 through 40084538, 40085637, 40085638, 40085642 through 40085644, 40085656, 40085666, 40085681, 40085683 through 40085698, 40085700, 40085702 through 40085707, 40085710 through 40085712, 40085723, 40085734 through 40085736, 40086464, 40088538, 40088544 through 40088548, 40088550 through 40088553, 40088574, 40088585, 40088586, 40089324 through 40089328, 40089333 through 40089340, 40089342 through 40089350, 40089359 through 40089363, 40089398, 40089402, 40089420, 40089421, 40092286, 40092287, 40092290, 40092291, 40092368 through 40092372, 40094139, 40094140, 40094142 through 40094149, 40095400 through 40095433, 40097292 through 40097298, 40097314 through 40097319, 40097321, 40098708, 40098711, 40098714, 40098716 through 40098719, 40098725 through 40098738, 40098751 through 40098754, 40100505 through 40100510, 40102542, 40102543, 40103791, 40103792, 40103796, 40103809, 40103810, 40103817, 40103820, 40103821, 40104726, 40104728, 40104733 through 40104747, 40105932, 40105933, 40105944 through 40105946, 40105952 through 40105954, 40106542 through 40106547, 40106549, 40106551, 40106552, 40106568 through 40106585, 40107959, 40107963, 40107964, 40107976 through 40107985, 40107990 through 40107996, 40107998, 40108817, 40108821, 40108832 through 40108846, 40108848 through 40108850, 40108853, 40109523 through 40109525, 40109531, 40109532, 40109534 through 40109544, 40109546, 40109550, 40110654 through 40110673, 40110684 through 40110688, 40110700, 40110702, 40110703, 40111775 through 40111783, 40111791 through 40111795, 40111804, 40111807 through 40111809, 40112657, 40112659 through 40112661, 40113737, 40113747 through 40113749, 40113755, 40113761, 40113762, 40113767, 40113768, 40113770 through 40113774, 40114922 through 40114928, 40114931 through 40114933, 40115990 through 40116023, 40117237 through 40117244, 40118114 through 40118116, 40118125, 40119844, 40119864, 40119867 through 40119873, 40120169 through 40120178, 40120182, 40120183, 40120908 through 40120917, 40120920, 40120924, 40120929, 40120930, 40120932, 40122181, 40122187, 40122189, 40122627, and 40132124
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The product was distributed nationwide to hospitals in the Unites States.
  • 제품 설명
    Datex-Ohmeda S/5 Anesthesia Delivery Units
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • 제조사 주소
    Datex-Ohmeda Inc, One Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA