Arcadis Orbic Mobile X-Ray System
FDA device recall Z-0438-06 · posted 2006-01-25 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- patient information can be stored in another patient's file.
- Action taken
- The recalling firm has issued a Customer Safety Advisory to the affected customers per Update Instructions SP030/05/S. The letter informs customers of the potential problem and provides a suggestion to avoid this issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 179 units
- Distribution
- The product was shipped to medical facilities nationwide.
- Date initiated
- 2005-12-12
- Date posted
- 2006-01-25
- Date terminated
- 2008-09-04
- 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 |
|---|---|---|
| ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) (K042793) | Siemens Medi Cal Solutions, Inc. | 2004-10-29 |