Axiom Artis System
FDA device recall Z-0848-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- patient images misidentified
- Action taken
- The recalling firm issued recall letters dated 5/28/03 to their accounts informing them of the problem.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 46 units
- Distribution
- The products were shipped to medical facilities nationwide.
- Date initiated
- 2003-05-28
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-25
- 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 ANGIOGRAPHY SYSTEM (K010721) | Siemens Medical Corp. | 2001-03-30 |