Recall Z-1235-2009 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
| Date | Apr 28, 2009 (initiated Jan 12, 2009) |
| Status | Terminated |
| Reason | Incorrect and/or incomplete data: Several potential safety issues while working with the syngo Image product including, but not limited to, data loss, errors in patient data due to different patient IDs, delays in image availability, inaccurate results during image measurements, incorrect review or diagnosis of displayed or printed images, measurement inaccuracies from the host modality and image |
| Root cause | Software design |
| Action | syngo Imaging has issued an Addendum to the User Manual, which was distributed to affected customers via Update Instructions IM118/08/S in November, 2008. Two safety related hotfixes (VB20G_HF4 and VB30A_HF26) will be released to those affected only after Update Instructions IM118/08/S has been performed. The addendum informs the user about safety relevant notes which pertain to syngo Imaging versions VB20G and VB30A. Update is a prerequisite for the following safety related hotfixes: VB20G_HF4 and VB30A_HF26. |
| Quantity | 55 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071114 | SYNGO IMAGING (VERSION V30) Siemens AG Medical Solutions, May 22, 2007 |