Recall Z-0174-2010 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
| Date | Nov 10, 2009 (initiated Sep 30, 2009) |
| Status | Terminated |
| Reason | Incomplete amount of image data; specifically, The image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption. |
| Root cause | Software design |
| Action | The recalling firm issued a "Customer Safety Advisory Notice" dated 9/14/09 to all affected customers via Update Instructions IM101/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. Questions regarding this issue are directed to the local SIEMENS Uptime Service Center. |
| Quantity | 2 units |
| Distribution | The product was shipped to medical facilities in NY and OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082430 | SYNGO IMAGING XS Siemens AG Medical Solutions, Nov 14, 2008 |