Recall Z-1303-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.via. Medical Device Software. Picture archiving and communications system.
| Date | Mar 20, 2018 (initiated Jan 8, 2018) |
| Status | Terminated |
| Reason | A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. The system will use the original values instead of displaying and saving corrected/modified values. Outdated information could be sent to the referring physician when creating the formal report in the reporting system. |
| Root cause | Software design |
| Action | Customer Advisory Notice SY065/17/P was sent to direct accounts. Firm is continuing to work on software solution. A workaround is available and is described in the Customer Advisory Notice. |
| Quantity | 236 units |
| Distribution | Device is software only. No products are distributed to wholesale dealers, distributers or retailers |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123375 | SYNGO.VIA Siemens AG, Nov 20, 2012 |