Recall Z-0438-06 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Arcadis Orbic Mobile X-Ray System
| Date | Jan 25, 2006 (initiated Dec 12, 2005) |
| Status | Terminated |
| Reason | patient information can be stored in another patient's file. |
| Root cause | Other |
| Action | 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. |
| Quantity | 179 units |
| Distribution | The product was shipped to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042793 | ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE) Siemens Medi Cal Solutions, Inc., Oct 29, 2004 |