Recall Z-1261-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
| Date | Jan 10, 2018 |
| Status | Terminated |
| Reason | When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical a |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install. |
| Quantity | 165 units |
| Distribution | Medical device software which needs to be installed. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123375 | SYNGO.VIA Siemens AG, Nov 20, 2012 |