Recalls / —

—#73843

Product

Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078.

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K010721, K021021

Affected lot / code info

Model number 7413078. Serial numbers: 46129, 46189, 46190, 46206, 46208, 46209, 46210, 46211, 46212, 46213, 46214, 46215, 46216, 46217, 46218, 46219, 46220, 46221, 46222, 46223, 46224, 46225, 46226, 46227, 46228, 46229, 46230, 46231, 46232, 46233, 46234, 46235, 46236, 46237, 46238, 46239, 46241, 46242, 46243, 46244, 46245, 46246, 46248, 46249, 46250, 46251, 46253, 46254, and 46255.

Why it was recalled

Incorrect contour finding: Image may be calibrated to the wrong size catheter.

Root cause (FDA determination)

Software design

Action the firm took

Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2008-09-02

Posted by FDA

2008-11-25

Terminated

2009-10-05

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.