AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors. AXIOM Artis is a angiography system d
FDA device recall Z-0312-2009 · posted 2008-12-09 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- System may switch to emergency fluoroscopy mode.
- Action taken
- 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
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 4 units
- Distribution
- Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
- Date initiated
- 2008-08-25
- Date posted
- 2008-12-09
- Date terminated
- 2010-01-26
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM (K052202) | Siemens Medical Solutions USA, Inc. | 2006-03-07 |