Recall Z-1235-06 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions, USA, Inc
KinetDx 4.0 Ultrasound Image Management System.
| Date | Jul 13, 2006 (initiated Apr 6, 2006) |
| Status | Terminated |
| Reason | The cardiologist's report comments may not be retained by the system due to a software bug. |
| Root cause | Other |
| Action | In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months. |
| Quantity | 244 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041029 | KINETDX Siemens Medi Cal Solutions, Inc., Jul 8, 2004 |