Recall Z-2852-2016 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
| Date | Sep 21, 2016 (initiated Aug 5, 2016) |
| Status | Terminated |
| Reason | Software error. Incorrect values for the volume calculation from a freehand VOI at the customer site. In volume calculations of prostate as well as in volume calculations of liver were too high. |
| Root cause | Software design |
| Action | Siemens sent an Customer Letter dated August 5, 2016, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. The letter informed customers of a software change VB10B_HF02 that they have implemented to address several issues. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the up |
| Quantity | 338 systems |
| Distribution | Distributed Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092519 | SYNGO.X Siemens AG Medical Solutions, Aug 27, 2009 |