Recall Z-0647-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
| Date | Jan 8, 2009 (initiated Nov 13, 2008) |
| Status | Terminated |
| Reason | Indicated orientation does not match actual orientation of the patient. |
| Root cause | Software design |
| Action | The recalling firm issued a Customer Safety Advisory dated 10/8/08 to affected customers via Update Instructions CT052/08/S. The letter informs customers of the potential issue and provides instructions to avoid its occurrence. Customers should consider "no saving of calculated Dual Energy data sets from non-supine and mirror-option scans via "Save Sets CT"-button." The firm also highly recommends for customers "to check the correct display of "left", "anterior" and "posterior"markings, e.g. by checking the position of the spine with respect to the posterior marking in the image." The error |
| Quantity | 374 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052775 | SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) Siemens AG Medical Solutions, Oct 31, 2005 |