AXIOM Artis System dBA 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.
FDA Recall Z-0313-2009 · Posted 2008-12-09
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2008-08-25
Date Terminated2010-01-26
Product Quantity6 units
Reason for Recall
System may switch to emergency fluoroscopy mode.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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