Recall Z-1038-2008 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
| Date | Apr 29, 2008 (initiated Dec 21, 2007) |
| Status | Terminated |
| Reason | Incorrect display: The orientation labels will be incorrectly displayed on the reconstructed InSpace 3-D image if the orientation was not originally HFS on the acquisition system. |
| Root cause | Software design |
| Action | Siemens Medical Solutions issued a Customer Safety Advisory Notice dated 12/21/07 to its customers to inform them of the problem and instructions to avoid the problem until the firm's representative is available to upgrade the software. |
| Quantity | 47 Units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040970 | LEONARDO Siemens Medical Systems, Inc., Jul 8, 2004 |