Recall Z-0984-03 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Axiom Aristos X-Ray System.
| Date | Jul 8, 2003 (initiated Apr 19, 2003) |
| Status | Terminated |
| Reason | software malfunction. May indicate that the image is flipped when it is not. |
| Root cause | Other |
| Action | The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived. |
| Quantity | 5 units |
| Distribution | The units were shipped to medical facilities nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013826 | AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) Siemens Medical Systems, Inc., Feb 1, 2002 |