Recall Z-0163-2009 ยท KPR System, X-Ray, Stationary
Siemens Medical Solutions USA, Inc
Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
| Date | Oct 20, 2008 (initiated Aug 25, 2008) |
| Status | Terminated |
| Reason | Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope. |
| Root cause | Equipment maintenance |
| Action | 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. |
| Quantity | 7 units |
| Distribution | Nationwide distribution including states of CA, IN, KY, UT, VA and WI. |
| 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 |