FDA Device

AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.

Hazard

System may switch to emergency fluoroscopy mode.

What You Should Do

Remedy

A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.

Products

AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure
Brand
Siemens Medical Solutions USA, Inc
UPC
Model number 7412807. Serial numbers: 35302, 35678, 35909, and 35916.

Units Affected

4 units