Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
FDA device recall Z-0163-2009 · posted 2008-10-20 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
- Action taken
- Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 7 units
- Distribution
- Nationwide distribution including states of CA, IN, KY, UT, VA and WI.
- Date initiated
- 2008-08-25
- Date posted
- 2008-10-20
- Date terminated
- 2008-10-20
- 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 ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) (K013826) | Siemens Medical Systems, Inc. | 2002-02-01 |