Recall Z-0314-2009 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis System dFA 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.
| Date | Dec 9, 2008 (initiated Aug 25, 2008) |
| Status | Terminated |
| Reason | System may switch to emergency fluoroscopy mode. |
| Root cause | Software design |
| 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. |
| Quantity | 2 units |
| Distribution | Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052202 | AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM Siemens Medical Solutions USA, Inc., Mar 7, 2006 |