Siemens Medical Solutions USA, Inc AXIOM Artis System dTA 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AXIOM Artis System dTA 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.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model number 7008605. Serial numbers: 55090, 55322, and 55469
Products Sold
Model number 7008605. Serial numbers: 55090, 55322, and 55469
Siemens Medical Solutions USA, Inc is recalling AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a due to System may switch to emergency fluoroscopy mode.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
System may switch to emergency fluoroscopy mode.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026