Recalls / —

—#50462

Product

AXIOM Artis MP, Angiographic x-ray system, model number 5904466

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K010721

Affected lot / code info

Model number number 5904466 - serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20158, 20165, 20170, 20171, 20172, 20175, 20178, 20179, 20180, 20181, 20182, 20183, 20185, 20188, 20196, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, and 20303.

Why it was recalled

C-arm gantry could rapidly descend without command during use.

Root cause (FDA determination)

Other

Action the firm took

In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The products were shipped to medical facilities nationwide.

Timeline

Recall initiated

2007-01-31

Posted by FDA

2007-03-08

Terminated

2009-05-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.