Recall Z-0168-2018 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. I
| Date | May 22, 2017 |
| Status | Terminated |
| Reason | Siemens is releasing a non-medical software application LTA Incomplete Archive Check Tool V1.0. It is intended to eliminate an issue that occurs during syngo.plaza de-archiving from Dicom LTA. It has been defined that the number of de-archived images is less than the count of the archived images for the series. The issues were discovered through Siemens Global Complaint Handling System. |
| Root cause | Software design |
| Action | Siemens sent an Customer Information Letter dated May 17, 2017. Customers Instructions: 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 update has been fully completed. For further questions, please call (610) 448-6478. |
| Quantity | 2 units |
| Distribution | Distribution to MN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132532 | SYNGO.PLAZA VB10A Siemens AG Healthcare, Dec 9, 2013 |