Recalls / —

—#81726

Product

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.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K073290

Affected lot / code info

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.

Why it was recalled

Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution.

Timeline

Recall initiated

2009-05-01

Posted by FDA

2009-06-16

Terminated

2009-09-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #81726. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.