Recall Z-1778-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.Via VB20A model 1049610
| Date | May 9, 2018 (initiated Mar 27, 2018) |
| Status | Terminated |
| Reason | Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values. |
| Root cause | Software design |
| Action | On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123375 | SYNGO.VIA Siemens AG, Nov 20, 2012 |