FDA Device recall Z-0168-2018
Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System…
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System… by Siemens Medical Solutions Usa, citing 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 fr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0168-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | MN |
Product
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. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific work flows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
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.
Identifiers
| code_info | non-medical software application Check Tool V1 .0 (L TA Incomplete Archive Check Tool V1 .0) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0168-2018%22
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