Recalls / —

—#27963

Product

Axiom Artis System

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K010721

Affected lot / code info

Part numbers 5904433, 5904649, 5904466, 5904441, 5904656, and 7007755. Serial numbers 10070, 10075, 10076, 10101, 10138, 10148, 10240, 10241, 10248, 10251, 10255, 10257, 10261, 10263, 10266, 14068, 20015, 20129, 20136, 25092, 25112, 25134, 25135, 25148, 25156, 25157, 25159, 25160, 25163, 25169, 25170, 28008, 28015, 28019, 28046, 28047, 28049, 28053, 28058, 28059, 28061, 32004, 32013, 32017, and 32019.

Why it was recalled

patient images misidentified

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

The products were shipped to medical facilities nationwide.

Timeline

Recall initiated

2003-05-28

Posted by FDA

2004-07-20

Terminated

2004-08-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27963. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.