AXIOM Artis MP, Angiographic x-ray system, model number 5904466
FDA device recall Z-0578-2007 · posted 2007-03-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- C-arm gantry could rapidly descend without command during use.
- Action taken
- In response to this issue, a Siemens Service Representative will visit the affected consignees beginning 02/01/2007, to check the spindle and adjust the spindle, if necessary.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 62 units
- Distribution
- The products were shipped to medical facilities nationwide.
- Date initiated
- 2007-01-31
- Date posted
- 2007-03-08
- Date terminated
- 2009-05-05
- 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 |