Events

Device Recall Mavig Portegra 2 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Siemens Medical Solutions USA, 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
    51947
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1443-2009
  • 사례 시작날짜
    2009-05-01
  • 사례 출판 날짜
    2009-06-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-09-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81726
  • 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
    Angiographic X-Ray System - Product Code JAK
  • 원인
    Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
  • 조치
    The recalling firm has decided to inspect all of the installed units for this condition and where necessary replace the missing clip. The recalling firm has issued an Update Instructions AX011/09/S dated 03.09, which provides instructions on how to perform a visual inspection of the Mavig Portegra 2 arm for the presence of the safety clip and the installation instructions on how to properly install the clip if it is missing.

Device

Device Recall Mavig Portegra 2
  • 모델명 / 제조번호(시리얼번호)
    Used with the following systems 1) Artis Zee floor Model number 10094135 - Serial numbers: 135102, 135109, 135117, 135120, 135122, 135125, and 135143; 2) Artis Zee ceiling Model number 10094137 - Serial numbers: 146103, 146104, 146107, 146113, 146116, 146119, 146122, 146123, 146136, 146137, and 146138; 3) Artis Zee biplane Model number 10094141 - Serial numbers: 153101, 153102, 153106, 153107, 153110, 153112, 153113, 153119, 153120, 153122, 153124, 153125, 153128, 153130, 153135, 153141, and 153153; 4) Artis Zee floor MN Model number 10094142 - Serial number: 140100; 5) Multistar D Model number 3772501 - Serial number: 1175 and 1667; 6) Axiom Iconos R200 Model number 5902775 - Serial number 2145; 7) Axiom Artis FC Model number 5904433 - Serial numbers: 10073, 10305, 10477, and 10488; 8) Axiom Artis MP Model number 5904466 - Serial numbers: 20313, 20321, 20338, and 20348; 9) Axiom Artis BC Model number 5904649 - Serial number: 14112; 10) Axiom Artis BA Model number 5904656 - Serial numbers: 28012, 28033, and 28067; 11) Axiom Artis TA Model number 7007755 - Serial numbers: 32042, 32048, and 32106; 12) Axiom Artis dTA Model number 7008605 - Serial numbers: 55070, 55217, 55218, 55219, 55220, 55223, 55228, 55230, 55231, 55232, 55233, 55238, 55241, 55243, 55246, 55249, 55250, 55254, 55256, 55259, 55260, 55262, 55263, 55269, 55273, 55274, 55276, 55277, 55279, 55282, 55284, 55285, 55286, 55287, 55288, 55289, 5292, 55294, 55298, 55299, 55304, 55305, 55306, 55307, 55308, 55310, 55312, 55316, 55318, 55320, 55322, 55325, 55338, 55342, 55343, 55355, 55356, 55358, 55359, 55362, 55365, 55368, 55369, 55374, 55375, 55376, 55377, 55378, 55382, 55384, 55388, 55392, 55394, 55395, 55396, 55399, 55400, 55401, 55404, 55405, 55407, 55408, 55409, 55410, 55411, 55414, 55415, 55416, 55423, 55425, 55426, 55435, 55436, 55438, 55439, 55441, 55443, 55455, 55461, 55462, 55466, 55468, 55470, 55473, and 55513; 13) Axiom Artis dFC Model number 7412807 - Serial numbers: 35511, 35516, 35525, 35528, 35529, 35535, 35536, 35538, 35540, 35545, 35556, 35560, 35566, 35571, 35580, 35581, 35599, 35600, 35601, 35603, 35610, 35613, 35623, 35627, 35629, 35634, 35649, 35652, 35655, 35659, 35663, 35664, 35665, 35666, 35672, 35678, 35684, 35690, 35698, 35704, 35707, 35727, 35728, 35730, 35736, 35739, 35741, 35743, 35744, 35745, 35750, 35762, 35768, 35776, 35778, 35782, 35783, 35784, 35787, 35788, 35793, 35802, 35810, 35821, 35828, 35831, 35834, 35836, 35937, and 37713; 14) Axiom Artis dTC Model number 7413078 - Serial numbers: 46036, 46071, 46097, 46111, 46112, 46115, 46117, 46118, 46120, 46122, 46125, 46129, 46133, 46134, 46138, 46139, 46143, 46144, 46145, 46146, 46147, 46153, 46156, 46158, 46162, 46163, 46168, 46170, 46171, 46172, 46174, 46178, 46179, 46180, 46186, 46189, 46190, 46194, 46196, 46198, 46201, 46202, 46203, 46205, 46208, 46209, 46210, 46213, 46215, 46216, 46218, 46219, 46220, 46221, 46223, 46224, 46225, 46226, 46229, 46231, 46233, 46236, 46241, and 46245; 15) Axiom Artis dMP Model number 7555365 - Serial numbers: 57054, 57073, 57076, 57077, 57089, 57111, 57116, 57144, 57155, 57156, 57171, and 57189; 16) Axiom Artis dFA Model number 7555373 - Serial numbers: 50074, 50079, 50081, 50087, 50093, 50101, 50105, 50120, 50132, 50139, 50142, and 50161; 17) Axiom Artis dFC Model number 7727717 - Serial numbers: 40031, 40050, 40061, 40067, and 40071; 18) Axiom Artis TC Model number 7728350 - Serial number: 30005; 19) Axiom Artis dBC Model number 7728392 - Serial numbers: 44152, 44157, 44163, 44165, 44171, 44174, 44189, 44190, 44193, 44195, 44198, 44201, 44206, 44215, 44218, 44223, 44224, 44227, 44229, 44242, 44243, 44251, 44254, 44255, 44262, 44263, 44265, 44267, 44268, 44271, 44275, 44277, 44278, 44280, 44282, 44289, 44290, 44292, and 44304; 20) Somatom Definition AS Model number 8098027 - Serial numbers: 64064, 64065, 64067, 64068, 64071, 64074, 64077, 64078, 64081, 64082, 64085, 64087, 64091, 64097, 64103, 64104, 64105, 64111, 64112, 64113, 64114, 64115, 64117, 64118.64122, 64123, 64138, 64140, 64142, 64145, 64154, 64164, 64166, 64168, 64169, 64170, 64171, 64172, 64177, 64178, 64179, 64180, 64181, 64190, 64194, 64199, 64202, 64212, 64214, 64228, 64231, 64232, 64235, 64236, 64239, 64241, 64243, 64244, 64245, 64246, 64247, 64248, 64253, 64258, and 64259.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281153 3-bulb surgery lamp, 115V.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA