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
  • 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
  • 7 Events

제조사

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